Associate Director/Director, Regulatory CMC

Role Summary

Associate Director/Director, Regulatory CMC – Lead Regulatory CMC activities for the In Vivo franchise, collaborating with cross-functional teams to devise innovative regulatory strategies and drive global submissions and interactions with health authorities.

Responsibilities

• Act as Regulatory CMC Lead for assigned programs providing strategic guidance to development teams on complex Regulatory CMC topics.
• In collaboration with the CMC team, plan, prepare, and submit high-quality CMC related applications including INDs and CTAs globally.
• Communicate with regulatory agencies on CMC topics, as appropriate.
• Lead and support Health Authority meeting strategy and preparation for CMC topics.
• Assess proposed technical changes and provide strategic regulatory guidance to enable global implementation.
• Drive adherence to CMC regulatory guidelines relevant for the development of transformative gene-based medicines.
• Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance and provide regulatory advice to program teams.
• Build and maintain strong relationships with internal and external stakeholders.

Qualifications

• Minimum: Bachelor’s degree required in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering.
• Prior regulatory CMC experience with a demonstrated track record of significant accomplishments:
• Associate Director:
  • 12+ Years of relevant experience with a bachelor's degree
  • 10+ Years of relevant experience with an advanced degree
• Director:
  • 15+ Years of relevant experience with a bachelor's degree
  • 12+ Years of relevant experience with an advanced degree
  • Must have direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies, with a demonstrated track record of significant accomplishments (e.g. successful IND, leading health authority interactions on CMC topics).
  • Current knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these principles to Regulatory CMC strategies for novel products.
  • Working knowledge of eCTD requirements for submission to US and ex-US regulatory agencies for IND, IMPD, CTA, BLA, NDA, MAA.
  • Exceptional ability to communicate verbally and in writing, and superb organizational skills required.
  • Ability to manage multiple priorities within a dynamic organizational and team structure.

Skills

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.

Education

• Preferred: PhD in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering is highly desirable.
• Regulatory Affairs CMC experience with mRNA/LNP is a plus.

Additional Requirements

• On-site requirements: Employees work at least three days on-site; certain lab-based and manufacturing positions are fully on-site.