Manager, Regulatory Affairs - Combination Products
Posted on Apr 6, 2021 by Pfizer
Act as the regulatory core team member for, and provides regulatory guidance to combination product project teams in a fast paced, highly visible, complex, and at times ambiguous and changeable environment.
Ability to present all information (regulatory and scientific) effectively, both orally and in writing, in a concise, logical, and persuasive manner. Excellent written and interpersonal communication skills.
Is responsible for the creation of all submission documentation for a project with a large portfolio of products. This includes correspondence, meeting requests and dossier content, including labeling. Must be able to set and communicate timelines for the regulatory submissions and for the delivery of supporting documentation. Must work with all functional areas to obtain needed information on time.
Anticipates the impact of potential team decisions on the regulatory strategy, timelines, project goals, and other programs and influence the team as needed.
Reviews scientific information to ensure the data is complete, sound, logical, and supports the program goals. Must be able to work with authors to ensure supporting information is clearly and logically written, in order to ensure it is submission ready.
Provides guidance to others on the creation of labeling or dossier contents. May approve labeling.
Interacts and effectively negotiate with regulatory authorities
Maintains awareness of applicable regulations and guidances and informs project teams of new information, along with its possible impact to the project, as appropriate.
Interprets regulations and ensures regulatory compliance. Exercises good judgment within company policy and health authority regulations.
Bachelor's degree in pharmacy, nursing, biology, chemistry, pharmacology, engineering or a related subject; is required.
5-8 years of experience in regulatory affairs in Medical Devices or Combination Products
Medical Device Regulatory Affairs experience required.
Candidate must understand the intent of the regulations to wisely navigate the discrepancies that exist in the application of each set of regulations to combination products, in order to ensure the decisions work well throughout the lifecycle of the products and to set appropriate precedent for future products and projects.
Master's degree is preferred. A Ph.D. is highly preferred.
Previous experience with combination product regulatory strategy and/or execution is beneficial.
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