Senior Manager Regulatory Affairs
A fast-growing, innovation-driven biopharmaceutical company is seeking a Senior Regulatory Manager to lead regulatory strategy and execution for early-phase programs across a diverse pipeline of novel therapies.
This is a unique opportunity to contribute to a global organization with a strong scientific foundation, a collaborative culture, and a commitment to delivering transformative medicines to patients worldwide.
What You'll Do:
- Develop and implement global regulatory strategies for early-stage development programs, including pre-IND, IND, and initial clinical trial submissions.
- Serve as the regulatory lead on cross-functional teams, providing strategic input and ensuring alignment with global regulatory requirements.
- Prepare and manage high-quality regulatory submissions in collaboration with internal teams and external partners.
- Lead communications with health authorities, including meeting preparation and response strategies.
- Monitor evolving regulatory landscapes and proactively assess impact on development programs.
What We're Looking For:
- Advanced degree in life sciences or related field (PhD, PharmD, or MS preferred).
- Minimum of 6 years of regulatory affairs experience in the biopharma industry, with a strong focus on early-stage development.
- Fluency in Chinese (Mandarin) is essential to support global collaboration and regulatory interactions.
- Strong understanding of global regulatory frameworks, especially U.S. and China.
- Experience in oncology, immunology, or other complex therapeutic areas is a plus.
Why Join Us?
- Be part of a mission-driven organization with a robust pipeline and global reach.
- Work alongside passionate teams in a collaborative, fast-paced environment.
- Enjoy competitive compensation, comprehensive benefits, and opportunities for professional growth.
Location: Flexible. Offices located in Boston, MA and New Jersey, with remote or hybrid options available.
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