Sr. Director, Regulatory CMC Strategy
Sr. Director, CMC Regulatory Strategy 1347396
Location: United States (Remote)
Science/ Focus: Small Molecule
Therapeutic Area: Stealth
Job Overview: The Sr. Director, CMC Regulatory Strategy will be responsible for the strategy and execution of CMC Regulatory activities across all drug development projects. This role can be remote and will report into the SVP, Technical Operations.
Responsibilities:
- Manage all Regulatory CMC aspects of programs including preparation and submission of CMC submissions
- Provide delivery of CMC documents including, regulatory authority requests, briefing books, IND/IMPD/CTA submissions, NDA/MAA submissions, and DMFs
- Review proposed manufacturing and quality changes for impact to filings and provide strategic regulatory guidance to implement possible changes
- Manage interactions with all regulatory authorities to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments and other submissions
Qualifications:
- BS in a scientific discipline (Advanced Degree a plus)
- 10+ years in Regulatory Affairs CMC
- Strong understanding of drug development process within a pharmaceutical company
- Extensive regulatory experience across value chain including IND/CTA/IMPD, NDA//MAA, lifecycle management, interactions with Regulatory Authorities, developing and implementing complex CMC regulatory strategies
- Prior success filing global submissions (IND, CTA, IMPD, NDA or MAA)
- Experience with the continuous manufacturing process
- Small molecule experience (preferred)
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.