We are seeking Regulatory Scientist GRACMC-Biotechnology to be a part of the company's global regulatory group to support global submissions and registrations. As the project leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support for clinical trial applications, market registrations and post-approval submissions. The Research Scientist in Global Regulatory Affairs – CMC Biotechnology will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the bioproduct portfolio. The regulatory scientist will be expected to develop and implement innovative regulatory strategies to advance the development of assigned product(s).
Deep technical knowledge of CMC drug development science(s)
Knowledge of bioproduct CMC global regulatory requirements and guidelines for conducting clinical trials and obtaining global product marketing registrations
Development of regulatory strategy to ensure alignment with current and evolving global regulatory expectations
Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning
Leads preparation, review, and finalization of CMC documents for global CTA and registration submissions and response to questions
Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content
Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members
B.S. degree in a science, engineering, or a related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar)
Five years of Bioproduct Regulatory CMC experience supporting clinical phases of development and/or commercialization, experience should include authoring CMC submission content, and involvement in clinical trial and commercial processes including response to questions
Additional preferences and Skills:
Experience in biotechnology drug substance and/or drug product development, commercialization, or manufacturing
Advanced degree preferred
Demonstrated deep knowledge of the biologic drug development process. Knowledge in new molecular modalities (e.g., oligonucleotides, cell and gene therapy) preferred but not required.
Experience planning for and participating in Health Authority meetings
Knowledge of major market procedures, regulations and practices. Awareness of evolving regulatory initiatives desirable.
Demonstrated ability to assess and manage risk in a highly regulated environment.
Demonstrated strong written, verbal and presentation communication skills.
Demonstrated leadership behaviors and negotiation and influence skills.
Demonstrated attention to detail
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.
Position Location: Indianapolis OR remote option available
Travel: minimal within the US