Published: November 8, 2018
- Responsible for leading the CMC regulatory function, the SR/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 our clients and 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.
- Responsible for aiding in 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 communicates regulatory CMC strategy, identifying key issues and remediation activities needed throughout project/product life cycle.
- BS in Science or Engineering degree with 10+ years pharmaceutical industry experience and a minimum of 8 years in Regulatory Affairs.
- Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents.
- Established working knowledge of regulatory guidelines and regulations (US and international).
- Regulatory experience supporting both development projects and commercial products.
- Strong knowledge of eCTD elements and structure and regulatory writing skills.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- 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.
- Professional demeanor and an excellent written and verbal communicator.
- Detail oriented and well organized.
- Good and thoughtful listener.
- Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
- Proficient in Microsoft Office suite and applications.
- Key to success: must be able work independently and as some of job may assigned and conducted from home offices.
- Must be hard worker abs ability to be flexible based on client needs.