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Job type: Permanent

Discipline: Senior/Director & VP, Officer /Associate, Project Manager

Location: United States

Proclinical is currently recruiting for a Manager/Senior Manager of Regulatory Strategy with a leading biotechnology company located Cambridge, MA. The Regulatory Strategy Manager/Senior Manager will manage the submissions and approvals of INDs, marketing applications, and other regulatory submissions (orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.)

Job Responsibilities:

Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.)
Work with RA-Strategist and project teams regarding the development and execution of regulatory strategy through the clinical development processes.
Coordinate aspects of regulatory submissions relevant to assigned projects or programs.
Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
Contribute, maintain the Core Data Sheet and support global labeling team meetings.

Skills and Requirements:

BA/BS degree in a scientific/engineering discipline required, Masters or PhD preferred.
5+ years of experience in the Pharmaceutical industry
3+ years of experience in Regulatory strategy, including specifically: Infectious Disease and Vaccine Development
Strong knowledge of current US and EU regulations, including vaccine regulatory pathways.
Ability to work both independently and within project teams, committees, etc. to achieve group goals.
Strong experience with CTD format and content regulatory filings
Exceptional written and oral communication
Experience with developing and implementing gap analysis and related competitive regulatory strategies
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EU
Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Knowledge and understanding of applicable regulations.
Experience in interpretation of regulations, guidelines, policy statements, etc.
Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbudamosi at (+1) 424-361-3900 or f.gbadamosi@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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