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.