Director/Senior Director, Regulatory CMC
Reporting to the SVP and Head of Regulatory Affairs, this is the Regulatory CMC Leadership role for the company, responsible for the strategic development and submission of regulatory filings for all projects, both in the US and globally.
In this position, you will drive the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC sections of INDs, CTAs, and original marketing applications (BLAs/MAAs), in close collaboration with global development teams, including Technical Operations and Quality, and with relevant external parties including contract manufacturing organizations, experts and global health authorities.
You will also be responsible to build a world-class Regulatory CMC organization and lead a team of talented individuals to support an advancing pipeline and corporate growth, and to shape Regulatory CMC policy on behalf of the company in your area of expertise and influence.
This role offers a rare opportunity for a highly motivated individual to join a company with a focus on science, innovation, collaboration and entrepreneurship, and build a world-class Regulatory CMC department with an aspiration to have meaningful impact and improve the lives of patients.
- Responsible for all CMC-related regulatory activities for all company projects
- Clearly define regulatory strategy for CMC components of all applications
- Manage planning, preparation and submission of high-quality CMC‑related applications globally
- Ensure that CMC-related applications, including INDs/CTAs, MAA and BLA are complete, well written, and meet all relevant requirements to achieve timely approval
- Lead negotiations with regulatory agencies to resolve CMC issues and foster proactive interactions with regulators globally
- Participate as needed in interactions with regulatory agencies during inspections
- Drive adherence to CMC regulatory guidelines relevant for the development of transformative gene-based medicines
- Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation
- Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance, and provide regulatory advice to project teams
Qualifications and Experience
- Master’s degree required in biochemistry, chemistry, biology or related pharmaceutical fields including chemical engineering; PhD degree highly desirable
- 5-10 years of relevant biopharmaceutical industry experience and demonstrable track record of accomplishments with at least 5 years of experience in CMC‐focused Regulatory Affairs preferably for biologics/vaccines or cellular therapies, and ideally with experience in BLA or MAA filings, late stage clinical development, and/or post-approval regulatory dossier life-cycle management.
- Superior ability to communicate verbally and in writing, and superb organizational skills
- Strong leadership qualities including strategic thinking, innovation, mentoring, collaboration
- Fundamental, current knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these requirements to develop regulatory submissions
- Experience preparing for and supporting/attending regulatory agency meetings.
- Working knowledge of eCTD requirements for submission to US and exUS regulatory agencies for IND, IMPD, BLA, NDA, MAA.
- 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.
If interested and qualified, please include Requisition # 2018-350 in the subject line when emailing resume to: firstname.lastname@example.org.
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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.