Posted in Other 29 days ago.
Type: Full Time
Reporting to the Senior Director of Regulatory Affairs CMC, this is a key role responsible for the strategic development and submission of regulatory filings for assigned 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, development partners, and global health authorities.
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 have meaningful impact on patients.
RESPONSIBILITIES * Responsible for all CMC-related regulatory activities for assigned projects
* 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
* Communicate with regulatory agencies on CMC topics, as appropriate
* 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
* Minimum of 5-7 years of relevant biopharmaceutical industry experience and demonstrable track record of accomplishments with at least 2 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
* Ability to manage multiple priorities within a dynamic organizational and team structure
* Fundamental, current knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these requirements to regulatory CMC strategies for novel products
* Experience preparing for and supporting/attending regulatory agency meetings preferred.
* Working knowledge of eCTD requirements for submission to US and exUS regulatory agencies for IND, IMPD, BLA, NDA, MAA.
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.
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