POSITION OBJECTIVE: Responsible for CMC regulatory functions, the Associate Director, Regulatory CMC will collaborate cross- functionally to help develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s) globally. Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will assist in the preparation and filing of regulatory CMC submissions and support company interactions with all Health Authorities for CMC topics. This individual will provide CMC regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and commercial products.
Athenex will consider this position to be located in Buffalo, NY, Cranford, NJ or remote.
Essential Job Functions/Responsibilities
· Combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation
· Lead the preparation and review of CMC sections of early phase (Ph1-2) regulatory submissions (IND/IMPD), as well as the interactions and responses with regulatory agencies
· Develop global CMC regulatory strategies for one or more investigational products through initial marketing applications and post-approval lifecycle maintenance
· Utilize understanding of GCP, GMP, and GLP to advise teams regarding these and other country-specific health authority regulations
· Advise teams regarding development activities and documentation needed for a successful marketing application, as needed
· Provide CMC regulatory guidance to cross-functional teams and key stakeholders, including external partners
· Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
· Work effectively on cross-functional teams and be the primary regulatory CMC contact for assigned products and projects
Required Education & Qualifications
- Bachelor’s degree is required. Advanced degree (M.S. or PharmD) in scientific, Regulatory Affairs, or related pharmaceutical field preferred.
- 5+ years pharmaceutical industry experience with a minimum of 3 years in regulatory affairs CMC or a related pharmaceutical development field. Experience with global clinical trial and marketing applications, eCTD submissions and electronic document management systems, highly desirable.
- Established working knowledge of pharmaceutical drug development and related global CMC regulations/guidelines.
- Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents.
- Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and/or product development meetings.
- Strong knowledge of eCTD elements and structure and regulatory writing skills.
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
- Strong communication skills both written and oral.
- Ability to multi-task and shift priorities rapidly to meet tight deadlines.
- Detail oriented and well organized.
- Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
- Proficient in Microsoft Office suite and applications.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.