Regulatory Affairs CMC Lead – Gene Therapy Programs

Crispr Therapeutics Inc in; Boston (MA); Hybrid; USD 165.000 - 180.000; Vollzeit

Zusammenfassung

CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines.

You will collaborate with cross-functional teams and partners to devise innovative regulatory strategies while coordinating with contract manufacturers and health authorities worldwide. Reporting to the Head of Regulatory Affairs, you will manage complex CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs,

Qualifikationen

• Bachelor's degree in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering.
• 12+ Years of relevant experience with a bachelor's degree; 10+ Years with an advanced degree (Associate Director).
• Direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies with accomplishments (e.g. IND).
• FDA, EMA and ICH regulations knowledge and application to CMC strategies for novel products.
• Working knowledge of eCTD requirements for US and ex-US submissions (IND, IMPD, CTA, BLA, NDA, MAA).
• Exceptional verbal/written communication and superb organizational skills.
• Ability to manage multiple priorities in a dynamic environment.

Aufgaben

• Act as Regulatory CMC Lead for assigned programs and provide strategic guidance on CMC topics.
• 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 regulatory guidance for global implementation.
• Drive adherence to CMC regulatory guidelines for gene-based medicines.
• Participate in regulatory intelligence related to global CMC regulations and guidance.
• Build and maintain relationships with internal and external stakeholders.

Kenntnisse

Regulatory leadership

Communication

Organization

Cross-functional collaboration

Multi-tasking

Ausbildung

Bachelor's degree in biochemistry/chemistry/biology or related field

PhD desirable

Tools

eCTD knowledge

IND/CTA submissions

Jobbeschreibung

CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines.

You will collaborate with cross-functional teams and partners to devise innovative regulatory strategies while coordinating with contract manufacturers and health authorities worldwide. Reporting to the Head of Regulatory Affairs, you will manage complex CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs,