Associate Director, Regulatory Affairs CMC

Associate Director, Regulatory Affairs CMC (Project Management) Job Description Company Overview

Founded over a decade ago,CRISPR Therapeutic sis a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY ® (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia.

CRISPR Therapeutic sis advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact,CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals .CRISPR

Therapeutics AGis headquartered inZug, Switzerland , with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California .

This position is a key leadership role for the development of the Zugo-cel CAR-T franchise orting to the Head of Regulatory Affairs, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise and implement innovative Regulatory strategies where little precedent exists.

You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.

• Act as Regulatory CMC Lead for assigned programs providing strategic guidance to development teams on complex Regulatory CMC topics.
• In close 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.

• 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
• 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.

• A PhD in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical…