Several Director Regulatory Affairs Positions - in both Pharmaceuticals and Medical Device
in the following locations: Chicago, Boston, LA , North Carolina
VP Chemistry Manufacturing and Control
Start up company - Philadelphia
VP Regulatory CMC
RTP, North Carolina
VP Regulatory Affairs - Biotechnology
Los Angeles, CA
Director of Clinical and Scientific Research
Hyderabad, India
Friday, March 14, 2008
Regulatory Affairs Managers & Associate Directors
Rapidly growing leader in the Medical Device Industry is looking to add talented professionals to their regulatory affairs team.
This is an exciting opporunity with temendous professional growth potential. If you are looking to advance your career in regulatory affairs and have experiance with class II medical devices, particularly if you work with any software driven / electromechanical products you will find this position very exciting.
Some of the responsibitities include:
Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;
Ensure that regulatory submissions for class II products, strong 510K submissions understanding
Monitor applicable regulatory requirements; assure compliance with company and external standards;
Identify risk areas and develop alternative courses of action including anticipation of Regulators responses through scenario planning and development of contingency plans;
Establish a leadership position on project development teams and ensure appropriate communication within RA and across other functional areas;
Develop and document sound regulatory decisions and justifications
Review of labels, labeling and promotional material for compliance with local and global regulations.
Lead and/or participate in RA and Corporate operational efficiency initiatives.
Requirements
Job Requirements
Bachelor’s degree in engineering or scientific discipline, with a minimum of 3 years direct experience in US regulatory submissions for hardware/software medical device regulatory submissions.
Higher degree/PhD will be an advantage.
International regulatory experience/exposure preferable.
Experience in hardware/software medical device development, regulations, standards, and current industry practices.
This company is offering a highly compedative salary and benifits package. For more information about these great Regulatory Affairs Jobs please call Katie Corliss @ 207-510-6666 or visit our website at www.executivesg.com to submitt your resume for consideration.
This is an exciting opporunity with temendous professional growth potential. If you are looking to advance your career in regulatory affairs and have experiance with class II medical devices, particularly if you work with any software driven / electromechanical products you will find this position very exciting.
Some of the responsibitities include:
Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;
Ensure that regulatory submissions for class II products, strong 510K submissions understanding
Monitor applicable regulatory requirements; assure compliance with company and external standards;
Identify risk areas and develop alternative courses of action including anticipation of Regulators responses through scenario planning and development of contingency plans;
Establish a leadership position on project development teams and ensure appropriate communication within RA and across other functional areas;
Develop and document sound regulatory decisions and justifications
Review of labels, labeling and promotional material for compliance with local and global regulations.
Lead and/or participate in RA and Corporate operational efficiency initiatives.
Requirements
Job Requirements
Bachelor’s degree in engineering or scientific discipline, with a minimum of 3 years direct experience in US regulatory submissions for hardware/software medical device regulatory submissions.
Higher degree/PhD will be an advantage.
International regulatory experience/exposure preferable.
Experience in hardware/software medical device development, regulations, standards, and current industry practices.
This company is offering a highly compedative salary and benifits package. For more information about these great Regulatory Affairs Jobs please call Katie Corliss @ 207-510-6666 or visit our website at www.executivesg.com to submitt your resume for consideration.
Thursday, February 7, 2008
Current Openings
The positions that we are working are always changing. This is not a complete list but I think a good overview.
As you know I specialize in Regulatory & Drug Safety, however my recruiters all have different specialities and we can help in almost every area.
We work both nationally as well as internationally.
RA Manager - International
NJ
AD Regulatory - Consumer Products - OTC
NJ
Sr. Supplier Quality Engineer
MA
Chief MSL
Charlotte
NC
AD Regulatory and Project Mgt
Philadelphia
PA
VP of CMC
Philadelphia
Sr. RA Liscensing Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
Dir. Reg Affairs - Pharma
Chicago
IL
RA Publisher
Chicago North
RA Liscensing Specialist
Waltham
MA
Medical Science Liaison
San Fransisco
CA
RA Manager
Openings in MA, NJ, IL and PA
Director Drug Safety
NJ
RA Project Manager
NJ
Dir Reg Affairs -Medical Device
IL
RA Specialist -Pharmacueticals
Openings in Submissions, Liscening and Operations
MA, IL, NJ
As you know I specialize in Regulatory & Drug Safety, however my recruiters all have different specialities and we can help in almost every area.
We work both nationally as well as internationally.
RA Manager - International
NJ
AD Regulatory - Consumer Products - OTC
NJ
Sr. Supplier Quality Engineer
MA
Chief MSL
Charlotte
NC
AD Regulatory and Project Mgt
Philadelphia
PA
VP of CMC
Philadelphia
Sr. RA Liscensing Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
Dir. Reg Affairs - Pharma
Chicago
IL
RA Publisher
Chicago North
RA Liscensing Specialist
Waltham
MA
Medical Science Liaison
San Fransisco
CA
RA Manager
Openings in MA, NJ, IL and PA
Director Drug Safety
NJ
RA Project Manager
NJ
Dir Reg Affairs -Medical Device
IL
RA Specialist -Pharmacueticals
Openings in Submissions, Liscening and Operations
MA, IL, NJ
Wednesday, October 3, 2007
This is a great artical on Personalized Medicine
Advancing Personalized Medicine- FDA’s Perspective and Role
Credit: FDA Consumer Health Information
e-published on MedicineandBiotech.com October 1st, 2007
Each person has a unique set of chemical blueprints that determine how his or her body looks and functions. These blueprints are contained in their own DNA which is made up of two twisting sequences or single strands that are able to be paired with another.
Here we discuss the following important topics of interest:
* What is Personalized Medicine?
* How Does Personalized Medicine Work?
* What's Involved?
* What are the Benefits of Personalized Medicine?
* What are the Challenges?
* FDA's Role
Medications have been prescribed over the years mostly by trial-and-error to reach the best dose for each patient. Typically, doctors diagnosed a condition and then selected what they believed was the most promising drug for treatment. If one didn't work, they'd try another.
Today, as science gives way to the understanding that people and diseases differ at the genetic or molecular level, doctors are learning to tailor treatments—or personalize them—to individuals more effectively.
By using "genomics," or the identification of genes and how they relate to drug treatment, doctors will be able to treat patients based on the actual biology of a disease and not just according to symptoms, and as an individual, not just a member of a population.
The Food and Drug Administration is especially interested in clearing the pathway for the development of safe and effective, leading-edge products that this burgeoning field of genomics is spawning—multiple tools, technologies, and sciences that will translate into the discovery and safety of drugs and medical products that the agency regulates.
By ensuring that new products and technologies are developed and made available to doctors and patients as effectively as possible, FDA believes this can only enhance the health of all Americans.
What is Personalized Medicine?
Personalized medicine uses information about a person's genetic makeup to tailor products that will detect, treat, or prevent disease in that person. The goal is to get the best medical outcomes by choosing treatments that work well with a person's genetic profile, or with certain characteristics in the person's blood or cells.
Scientifically, personalized medicine is known as pharmacogenomics (drugs combined with genes), or how genetic differences in individuals affect the way people respond to drugs. The science of pharmacogenomics tries to answer questions like: Why do some people get cancer and others don't? Why is cancer more aggressive in this person and not in that one? Why does this drug work for him and not for her? Why do some people show toxicity to a drug while others don't? Why does someone need twice the standard dose to be effective? And why do others need only half of the standard dose?
How Does Personalized Medicine Work?
Someone diagnosed with colon cancer today would receive a treatment based on standard medication and dosing guidelines for that disease. The doctor might factor in weight, age, medical history, and how any blood relatives might have reacted to a certain medication. But the doctor cannot know how that person will respond to the medication, which may help the cancer or have no affect at all. The person could experience terrible side effects or none at all. And, it may be necessary for several revisits to the doctor for adjusting the dosage or to switch medications. This is considered the trial-and-error approach to medicine.
With personalized medicine, people may be able to take a genetic test that can help determine which diseases they are likely to develop, and a blood test to help determine which genetic variations they may have—even before they've taken a single dose of medicine. Based on test results, the doctor could tailor a patient's treatment by avoiding using a certain drug, prescribing another, or altering a dose to match the body's genetics. A person's unique genetic profile can help a doctor personalize treatments.
What's Involved?
New technologies and tools have been developed as a direct result of the nation's effort to understand DNA—deoxyribonucleic acid—the blueprint that determines how each person’s body looks and functions. Those technologies and what they intend to accomplish within personalized medicine include:
Functional genomics—measures gene expression under normal and troubled conditions and attempts to predict the gene expression profiles for these conditions.
Structural genomics—addresses questions concerning individual genetic differences and the impact that these genetic differences have on the development of disease.
Proteomics—seeks to discover all proteins in a living organism, and determine their function and how they affect each other.
Metabolomics—studies all the molecules involved in metabolism (metabolites) in a living organism by evaluating tissues and body fluids, such as urine, blood, plasma, and saliva for changes.
Genomics and Medical Devices—understands how certain diseases, or increased risks pass from generation to generation.
Nanotechnology—uses materials or devices at the level of molecules and atoms too small to be seen with a conventional laboratory microscope.
What are the Benefits of Personalized Medicine?
* Diagnosing disease or predicting risk of disease.
* Determining whether a treatment is working or not.
* Monitoring healthy people to detect early signs of disease.
* Producing safer drugs by predicting the potential for adverse effects earlier.
* Targeting specific groups of people most likely to benefit from a drug, while keeping its use from those who may be harmed by it.
* Providing researchers the opportunity to get a global view of the events that are always changing within a cell.
* Producing new classes of structural materials that are expected to bring about lighter, stronger, smarter, cheaper, cleaner, and more precise medical products.
What are the Challenges of Personalized Medicine?
Personalized medicine is new and still in the early stages. Using a pharmacogenomic test to determine who will respond to a treatment or who should not get a treatment may narrow the market for certain drugs—manufacturers may be reluctant to invest time and money. Identifying all of the genetic variations (perhaps millions) that may exist could take years. How a person responds to a medication may not be determined by just one gene, but rather, several genes and their products interacting with each other.
This new way of doing things likely will be expensive and time-consuming.
FDA's Role
Tests that scientists are beginning to use on body fluids and cells to determine the variations of disease were not available in the past. Such tests, coupled with the understanding of the expression of each individual’s genes, will allow scientists to detect differences between patients and diseases much more precisely. FDA's Critical Path Initiative—the scientific process through which a medical product is transformed from discovery to development—is organizing work across 76 science and regulatory areas to improve medical product development, especially for gene-oriented drugs and diagnostic tests.
FDA encourages applications for approval of new tools and technologies for a number of reasons:
* The ability to bridge data gaps that exist in preclinical studies (animals) and clinical studies (humans) used to assess the safety and effectiveness of products it regulates.
* Technologies can be used not only in the discovery phase of potential products, but also in the safety and effectiveness evaluation phase of development and submission to the agency.
* Adverse events likely can be predicted prior to the approval and marketing of a product.
FDA's role in personalized medicine will be to bring balance to an evolving science in a way that does not inhibit its growth. Thousands of cancer patients are already benefiting from several targeted drugs, such as Tarceva and Gleevec, both known to work better in people with certain genetic profiles. Hope for the future is that personalized medicine will improve the safety, quality and effectiveness of health care for every American.
Credit: FDA Consumer Health Information
e-published on MedicineandBiotech.com October 1st, 2007
Each person has a unique set of chemical blueprints that determine how his or her body looks and functions. These blueprints are contained in their own DNA which is made up of two twisting sequences or single strands that are able to be paired with another.
Here we discuss the following important topics of interest:
* What is Personalized Medicine?
* How Does Personalized Medicine Work?
* What's Involved?
* What are the Benefits of Personalized Medicine?
* What are the Challenges?
* FDA's Role
Medications have been prescribed over the years mostly by trial-and-error to reach the best dose for each patient. Typically, doctors diagnosed a condition and then selected what they believed was the most promising drug for treatment. If one didn't work, they'd try another.
Today, as science gives way to the understanding that people and diseases differ at the genetic or molecular level, doctors are learning to tailor treatments—or personalize them—to individuals more effectively.
By using "genomics," or the identification of genes and how they relate to drug treatment, doctors will be able to treat patients based on the actual biology of a disease and not just according to symptoms, and as an individual, not just a member of a population.
The Food and Drug Administration is especially interested in clearing the pathway for the development of safe and effective, leading-edge products that this burgeoning field of genomics is spawning—multiple tools, technologies, and sciences that will translate into the discovery and safety of drugs and medical products that the agency regulates.
By ensuring that new products and technologies are developed and made available to doctors and patients as effectively as possible, FDA believes this can only enhance the health of all Americans.
What is Personalized Medicine?
Personalized medicine uses information about a person's genetic makeup to tailor products that will detect, treat, or prevent disease in that person. The goal is to get the best medical outcomes by choosing treatments that work well with a person's genetic profile, or with certain characteristics in the person's blood or cells.
Scientifically, personalized medicine is known as pharmacogenomics (drugs combined with genes), or how genetic differences in individuals affect the way people respond to drugs. The science of pharmacogenomics tries to answer questions like: Why do some people get cancer and others don't? Why is cancer more aggressive in this person and not in that one? Why does this drug work for him and not for her? Why do some people show toxicity to a drug while others don't? Why does someone need twice the standard dose to be effective? And why do others need only half of the standard dose?
How Does Personalized Medicine Work?
Someone diagnosed with colon cancer today would receive a treatment based on standard medication and dosing guidelines for that disease. The doctor might factor in weight, age, medical history, and how any blood relatives might have reacted to a certain medication. But the doctor cannot know how that person will respond to the medication, which may help the cancer or have no affect at all. The person could experience terrible side effects or none at all. And, it may be necessary for several revisits to the doctor for adjusting the dosage or to switch medications. This is considered the trial-and-error approach to medicine.
With personalized medicine, people may be able to take a genetic test that can help determine which diseases they are likely to develop, and a blood test to help determine which genetic variations they may have—even before they've taken a single dose of medicine. Based on test results, the doctor could tailor a patient's treatment by avoiding using a certain drug, prescribing another, or altering a dose to match the body's genetics. A person's unique genetic profile can help a doctor personalize treatments.
What's Involved?
New technologies and tools have been developed as a direct result of the nation's effort to understand DNA—deoxyribonucleic acid—the blueprint that determines how each person’s body looks and functions. Those technologies and what they intend to accomplish within personalized medicine include:
Functional genomics—measures gene expression under normal and troubled conditions and attempts to predict the gene expression profiles for these conditions.
Structural genomics—addresses questions concerning individual genetic differences and the impact that these genetic differences have on the development of disease.
Proteomics—seeks to discover all proteins in a living organism, and determine their function and how they affect each other.
Metabolomics—studies all the molecules involved in metabolism (metabolites) in a living organism by evaluating tissues and body fluids, such as urine, blood, plasma, and saliva for changes.
Genomics and Medical Devices—understands how certain diseases, or increased risks pass from generation to generation.
Nanotechnology—uses materials or devices at the level of molecules and atoms too small to be seen with a conventional laboratory microscope.
What are the Benefits of Personalized Medicine?
* Diagnosing disease or predicting risk of disease.
* Determining whether a treatment is working or not.
* Monitoring healthy people to detect early signs of disease.
* Producing safer drugs by predicting the potential for adverse effects earlier.
* Targeting specific groups of people most likely to benefit from a drug, while keeping its use from those who may be harmed by it.
* Providing researchers the opportunity to get a global view of the events that are always changing within a cell.
* Producing new classes of structural materials that are expected to bring about lighter, stronger, smarter, cheaper, cleaner, and more precise medical products.
What are the Challenges of Personalized Medicine?
Personalized medicine is new and still in the early stages. Using a pharmacogenomic test to determine who will respond to a treatment or who should not get a treatment may narrow the market for certain drugs—manufacturers may be reluctant to invest time and money. Identifying all of the genetic variations (perhaps millions) that may exist could take years. How a person responds to a medication may not be determined by just one gene, but rather, several genes and their products interacting with each other.
This new way of doing things likely will be expensive and time-consuming.
FDA's Role
Tests that scientists are beginning to use on body fluids and cells to determine the variations of disease were not available in the past. Such tests, coupled with the understanding of the expression of each individual’s genes, will allow scientists to detect differences between patients and diseases much more precisely. FDA's Critical Path Initiative—the scientific process through which a medical product is transformed from discovery to development—is organizing work across 76 science and regulatory areas to improve medical product development, especially for gene-oriented drugs and diagnostic tests.
FDA encourages applications for approval of new tools and technologies for a number of reasons:
* The ability to bridge data gaps that exist in preclinical studies (animals) and clinical studies (humans) used to assess the safety and effectiveness of products it regulates.
* Technologies can be used not only in the discovery phase of potential products, but also in the safety and effectiveness evaluation phase of development and submission to the agency.
* Adverse events likely can be predicted prior to the approval and marketing of a product.
FDA's role in personalized medicine will be to bring balance to an evolving science in a way that does not inhibit its growth. Thousands of cancer patients are already benefiting from several targeted drugs, such as Tarceva and Gleevec, both known to work better in people with certain genetic profiles. Hope for the future is that personalized medicine will improve the safety, quality and effectiveness of health care for every American.
RAPS Conference 2007
It was great to see so many of you at RAPS 2007!!!!
Those of you who I didn't get a chance to meet hopeful we can connect another time. What an exciting time to be in regulatory. I am always just thrilled to hear about all of the new products and so many companies are working on.
Have a great day!
Katie
Those of you who I didn't get a chance to meet hopeful we can connect another time. What an exciting time to be in regulatory. I am always just thrilled to hear about all of the new products and so many companies are working on.
Have a great day!
Katie
Tuesday, September 18, 2007
RAPS 2007 Annual Conference
I am going to be attending the RAPS 2007 Annual Conference in Boston on Monday September 24th.
My hope is to continue learning about this exciting field and how I as a recruiter can best serve all of you in filling positions or searching for a new job.
I am looking to network with as many regulatory professionals as possible and an open to your suggestion about what trainings it maybe helpful for me to attend and who else I should meet while I am there.
If you are planning to attend please let me know I would love to meet up and say hello!
Katie Corliss
207-510-6666 ext 122
kcorliss@executivesg.com
My hope is to continue learning about this exciting field and how I as a recruiter can best serve all of you in filling positions or searching for a new job.
I am looking to network with as many regulatory professionals as possible and an open to your suggestion about what trainings it maybe helpful for me to attend and who else I should meet while I am there.
If you are planning to attend please let me know I would love to meet up and say hello!
Katie Corliss
207-510-6666 ext 122
kcorliss@executivesg.com
3rd Quarter Update
I just wanted to drop you a quick note to let all of you know that with the 3rd quarter quickly coming to an end there are a lot of companies looking at ramping up their regulatory groups.
I am working on some great new openings and would love the chance to share them with you. If you haven't been currently looking for a new position this maybe a great time to just listen to what is out there and see if something peeks your interest.
Please let me know the best way for us to catch up by phone.
Have a great day!
Katie Corliss
Senior Vice President, Life Science Practice
Executive Search Group
207-510-6666 ext 122
kcorliss@executivesg.com
I am working on some great new openings and would love the chance to share them with you. If you haven't been currently looking for a new position this maybe a great time to just listen to what is out there and see if something peeks your interest.
Please let me know the best way for us to catch up by phone.
Have a great day!
Katie Corliss
Senior Vice President, Life Science Practice
Executive Search Group
207-510-6666 ext 122
kcorliss@executivesg.com
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