Director, Regulatory CMC Job Description Template
Our company is looking for a Director, Regulatory CMC to join our team.
Responsibilities:
- Authoring or managing preparation of CMC‑focused regulatory submissions;
- Serving as Regulatory CMC liaison with partner companies and contract manufacturers;
- Providing strategic guidance on global regulatory CMC requirements to senior management and cross-functional project teams;
- Partnering with Quality Assurance and Product Development to ensure regulatory submission accuracy and compliance;
- Managing regulatory consultants and contractors.
Requirements:
- Experience authoring/editing regulatory CMC and other technical documents;
- High attention to detail, and excellent proofreading and editing skills;
- Experience with regulatory submissions (IND, CTA, NDA, MAA, etc.) in eCTD format;
- Qualifications: Bachelor’s or Master’s degree in life sciences (PharmD or PhD preferred);
- Good knowledge of the overall drug development process;
- High‑level competence in pertinent software (e.g., Word, PowerPoint, EndNote);
- Excellent written and oral communication and interpretive skills;
- Demonstrated ability in project management, with overlapping priorities and aggressive timelines;
- Minimum 10 years of Regulatory CMC experience in the biotech or pharmaceutical industry;
- Experience with small molecule drug development is preferred;
- Familiarity with all pertinent regulations and guidances.