Friday, March 21, 2008

RA Manager / Senior Regulatory Affairs Manager

Regulatory Affairs Manager / Senior Regulatory Affairs Manager

Exciting opportunity for to work with an established multinational company in their vaccines division! This is a chance to be part of having a lasting impact on humanity as this division is working on vaccines in some critical areas such as pandemic flu, seasonal flu as well as others.
They are seeking an individual who have a strong scientific and regulatory skills who have some experience with vaccines.

The responsibilities are as follows:
Develop and execute regulatory plans for complex US Vaccine projects including new product development and maintenance of licenses/authorizations for existing marketing authorizations
Provide regulatory input on nonclinical, clinical and CMC development issues
Represent or lead the RA function on assigned cross-functional project teams
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
Establish appropriate communication within RA and other functions primarily at project level
Perform gap analysis and propose solutions
Develop and document sound regulatory decisions and justifications
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
May provide direct supervision of individuals
May review promotional material or SOP’s for compliance with local and global regulations

The idea candidate will have the following qualifications:
Strong basis of Regulatory knowledge, previous experience in vaccine development will be an advantage
Strong Scientific Knowledge
Direct Experience with FDA and other Health Authorities
Experience with BLA/NDA and supplement submissions
Ability to manage complex projects and timelines in a matrix team environment
Experience working on global project teams
Strong verbal and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
Master's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA, including managing people or projects.
Higher degree/PhD will be an advantage

All are encouraged to apply. For additional regulatory affairs openings please visit our website
www.executivesg.com


Friday, March 14, 2008

Current Openings

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

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.