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Associate Director of Regulatory Strategy
1 month ago
The Role:
Moderna Therapeutics is seeking a seasoned regulatory professional to support the development and registration of oncology therapeutics and vaccines based on messenger RNA technology. This role requires a forward-thinking, creative, and agile individual who can anticipate and address regulatory challenges in the US and ex-US markets.
The successful candidate will be a strategic leader within the Global Regulatory Strategy, Oncology group, responsible for developing and executing regulatory plans for the US market and ex-US regions for assigned programs at various stages of product development. They will articulate clear and compelling regulatory strategies, highlighting risks and opportunities when appropriate. Prior regulatory experience with oncology drug development is highly desirable.
Key Responsibilities:
- Develop and execute regulatory plans for the US market and ex-US regions for assigned programs at various stages of product development.
- Articulate clear and compelling regulatory strategies, highlighting risks and opportunities when appropriate.
- Collaborate with cross-functional teams to ensure regulatory strategies are aligned with global product strategies.
- Lead the strategy for US FDA interactions, including development of content, format, and accountability for regulatory submissions and related supplements and amendments.
- Conduct risk assessments and identify potential areas of regulatory concern for assigned projects or programs.
- Review and approve regulatory documents prior to submission to respective regulatory authorities.
- Serve as primary point of contact and negotiate directly and effectively with FDA and other health agencies for assigned programs.
Requirements:
- BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD, or PhD preferred.
- 7+ years of experience in the Pharmaceutical industry preferred.
- 5+ years of experience in Regulatory strategy or relevant training/experience preferred.
- Experience in oncology therapeutics highly preferred.
- Demonstrated track record in being a leader on functional and cross-functional teams.
- Strong knowledge of current US regulations and knowledge of ex-US regulations.
- Strong experience with CTD format and content of regulatory filings.
- Exceptional written and oral communication.
- Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance at least in the US.
About Moderna:
Moderna is a leading biotechnology company that is pioneering the use of messenger RNA technology to develop innovative therapeutics and vaccines. We are committed to making a meaningful impact on society and are seeking talented individuals who share our passion for innovation and our commitment to excellence. We offer a comprehensive and innovative suite of benefits, including highly competitive medical, dental, and vision coverage options, flexible spending accounts, and a generous paid time off policy. We are proud to be an equal opportunity workplace and are committed to diversity, equity, and inclusion. If you are a motivated and talented individual who is passionate about making a difference, we encourage you to apply for this exciting opportunity.
