about 2 months ago
We are seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet aggressive timelines for assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics.
Essential Functions of the Job:
- Lead, develop, and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions for investigational, market, and post-approval applications.
- Develop regulatory CMC strategy and execute in the preparation of timely responses to small molecule CMC regulatory questions, pre-meeting packages, and interactions with Health Authorities as needed for the assigned project.
- Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects.
- Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior management in a timely way.
- Lead or contribute to development of internal small molecule CMC regulatory guidance and working
- Ensure proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project.
- Provide CMC regulatory review of cross-functional documents, e.g., clinical protocols, investigator brochures, etc. for the assigned project.
- Provide comments on new global guidance through the company’s commenting process.
The position may manage direct report(s).
- 5+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience.
- A proven record of leading Health Authority interactions, CTA, NDA/MAA, post-approval preparation, submission, and subsequent response to HA queries.
- In-depth knowledge of ICH requirements and US/EU regulatory requirements.
- Knowledge/experience with regulatory requirements for rest of world regions and GMP regulation is a plus.
- Demonstrated leadership as a people manager.
- Experience in authoring complex technical documents, CMC regulatory CTD (M2 and M3) sections, and life cycle management.
- Educational background in scientific discipline and expertise in at least one area in pharmaceutical development (e.g., chemical process, formulation, manufacturing, QC, QA, etc.).
- Excellent oral and written communications skills are a must-have.
- The candidate should be detail-oriented, self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
- Familiarity with Veeva Vault is a plus. #LI- AM2
Education Required: BA/BS Degree in scientific discipline, MS/PhD preferred
Computer Skills: Microsoft 360
Travel for Work: As needed