Associate Director, Regulatory Affairs CMC

Responsibilities

• 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 provide regulatory advice to program teams.
• Build and maintain strong relationships with internal and external stakeholders.

Requirements

• 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.

Qualifications

• Bachelor’s degree in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering.
• PhD in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering is highly desirable.
• Late phase IND/CTA/GMO submission authoring, and understanding of FDA/EMA requirements for corresponding dossier development.

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.

Benefits

• The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role.
• CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.