POSITION OBJECTIVE: Responsible for leading the CMC regulatory function, the Director, Regulatory CMC will collaborate cross- functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will lead the preparation and filing of regulatory CMC submissions and manage the 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.
This position will be located in either Schaumburg, IL or Buffalo, NY.
Essential Job Functions/Responsibilities
• Plans, manages, and executes CMC regulatory activities for assets in various phases of development.
• Responsible for the coordination, authorship, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submission and marketing applications to FDA and international regulatory authorities), which support clinical programs, CMC and quality.
• Provides quality/CMC review for clinical study protocols, clinical study reports, investigator brochures and other relevant reports.
• Develops and implements CMC Regulatory strategies for assigned projects and provides advice and strategic guidance to development teams.
• Develops and communicates regulatory CMC strategy, identifying key issues and remediation activities needed throughout project/product life cycle.
• Serves as the Regulatory lead in Health Authority meetings and leads preparation of CMC activities for meetings with Health Authorities.
• Interacts directly and indirectly with FDA and international Health Authorities, as necessary.
• Ensures line management and key stakeholders are apprised of ongoing developments.
• Maintains current knowledge of relevant US and international guidances, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
Required Education & Qualifications
- BA/BS degree is required. Advanced degree (M.S. or Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field preferred.
- 8 to 10 years pharmaceutical industry experience with a minimum of 5 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.