Sr Manger, Regulatory Affairs - Vaccine

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.


Responsible and accountable for all operational aspects of regulatory submissions in the United States, including submission planning and technical support, for Baxter's developmental products in the Vaccines Business Unit. Maintains relationship and communication with US regulatory authorities and joint venture partners.

1) Participate in the preparation and review of US license applications (IND, BLA, Master Files, etc.) for vaccine projects

2)Act as primary contact with regulatory authorities including the planning and leadership of meetings

3)Participate in global regulatory strategy development, planning, and implementation for multiple complex programs and platforms

4)Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards

5)Assess impact of new regulations and provide feedback

6)Maintain appropriate communication within the RA function, SBU marketing, and other functions primarily at the project team level

7)Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks

8)Provide technical and strategic input for regulatory decisions


Qualifications
1) Expert Regulatory knowledge


2) Scientific Knowledge


3) Ability to oversee multiple projects in a matrix team environment


4) Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities


5) Excellent oral and written communication and presentation skills


6) Ability to accomplish results through others


7) Ability to lead, coach, and motivate others


8) Bachelor's degree or country equivalent in related scientific discipline with a minimum of 7 years experience in RA, ideally including work experience with vaccine products


9) Higher degree/PhD will be an advantage


As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits.




To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V