Reporting to the Executive Director of Technical Regulatory Affairs, the Director will be responsible for development and execution of CMC/technical regulatory strategy, including management of high quality regulatory submissions and leading global Health Authority interactions for one or more products within Dermira’s portfolio. This individual will work closely and collaboratively with department management and cross-functional technical/CMC teams and provide regulatory support and guidance and ensure all applicable regulatory requirements are considered and appropriately incorporated into the product regulatory strategy. This position provides a unique opportunity to work on both small and large molecule drugs and their device combinations.
- Works collaboratively with cross-functional team leads and develops and communicates regulatory CMC strategy while ensuring compliance to regulatory requirements of relevant markets and Dermira policies and Standard Operating Procedures. Identifies key CMC regulatory issues and remediation activities needed throughout project/product life cycle.
- Responsible for regulatory aspects of preparation, review and timely filing and maintenance of CMC sections of investigational, licensure and post-approval regulatory submissions such as INDs, CTAs, NDAs, BLAs, Annual Reports and briefing documents to FDA and other international regulatory authorities. Works with CMC functional Subject Matter Experts to provide timely responses to CMC regulatory questions from global health authorities. Coordinates CMC regulatory submissions with Global Regulatory Affairs.
- Manages, tracks, and assures accountability to global regulatory CMC commitments.
- Provides quality/CMC regulatory review for clinical protocols/reports and investigator brochures.
- As delegated, lead Health Authority interactions with on technical regulatory topics (e.g. CMC End of Phase 2 and EMA/CHMP Scientific Advice Meetings). Liaise with Health Authority Program Managers on assigned projects.
- Work collaboratively and strategically with Dermira global regulatory affairs personnel on strategy and implementation of CMC activities relative to other project submissions.
- Supports cross-functional management/team in risk assessments, change control and product complaints.
- Maintains current knowledge of relevant US and international guidances and regulations that affect CMC pharmaceutical drug and combination product development and approval.
- May mentor or manage personnel based on growth of Dermira’s product portfolio.
- Understands trends and requirements in the global market and government regulatory activities and the impact of changes on the company’s product portfolio to assess the cost benefit, risk management implications for the company.
- Obtains and manages external expert advice and resources as required to develop and achieve CMC regulatory plans. Other responsibilities as required.
- Bachelor’s degree (BA/BS) minimum requirement. Advanced degrees such as Masters, Ph.D. Pharm. D. preferred. Candidates with educational background in scientific/technical disciplines such as chemistry, cell biology, pharmaceutics/pharmacy, or engineering are encouraged to apply.
- At least 10 years of experience in pharmaceutical or associated healthcare manufacturing industry desired, with 6 – 8 years of technical/CMC regulatory experience in small molecule or biologic drug products. Combination product experience with biologics highly desirable.
- Experience leading Health Authority interactions on CMC regulatory topics.
- Extensive CMC regulatory filing experience, familiarity with eCTD submissions, and excellent writing/communication skills required.
- Excellent understanding of US and global CMC regulatory requirements in pharmaceuticals, biologics and/or medical devices. Understanding of US FDA combination product regulations/guidelines and EU MDD/MDR a plus.
- Experience with providing successful CMC/technical regulatory leadership to pharmaceuticals/biologics and/or drug/device combination products.
- Enthusiastic and self-motivated individual with strong interpersonal skills.
- Ability to set priorities and respond flexibly to program changes.