Executive Director, Regulatory Affairs CMC

Responsibilities

• Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs, MAAs etc.) through product lifecycle.
• Proactively identify regulatory risks, opportunities, and mitigation strategies in alignment with objectives, and communicate to management, as needed
• Provide strategic regulatory guidance to TechOps and Quality organizations to ensure global compliance and readiness for clinical and commercial supply
• Serve as the primary interface with global regulatory agencies for CMC-related negotiations, milestone meetings, and information requests.
• Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.
• Manage junior team members and contractors to support development activities

Education & Experience

BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required

12 years’ experience in Regulatory Affairs CMC in Pharma/Biotech 

Strong negotiation skills with health authorities (e.g. FDA, EMA) as well as submissions

Experience with leading IND and Marketing Applications

Experience with antibody drug conjugates and biologics

Strong analytical, strategic thinking, and problem-solving skills.

Excellent communication and leadership abilities; able to influence across all levels of the organization.

Ability to thrive in a fast-paced, ambiguous environment while managing competing priorities.

Commitment to fostering a diverse and inclusive workplace

What We Offer

Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment

Competitive compensation, including base salary, performance bonus, and equity

100% employer-paid benefits package

Flexible PTO; also, two, one-week company-wide shutdowns each year

A commitment to your professional development, with access to resources, mentorship, and growth opportunities

Salary Range