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

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