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Job type: Permanent

Discipline: CMC

Location: United States

Director, Regulatory Affairs CMC - Permanent - Rockville, MD

Are you passionate about driving impactful regulatory strategies in a rapidly evolving environment?

Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product lifecycle and contribute to the development of cutting-edge therapies.

Primary Responsibilities:

As a Director in Regulatory Affairs - CMC, the successful candidate will be the go-to expert for global CMC strategy, overseeing regulatory submissions and aligning with cross-functional teams in CMC, Manufacturing, and Quality. This role will guide the development and implementation of CMC plans, ensuring compliance across major territories. Working closely with regulatory leadership, this role will contribute to the strategic and operational goals of high-impact projects.

Skills & Requirements:

The successful candidate must have over 10 years of experience in regulatory affairs or related fields, and be an expert in biologics and advanced therapies. Possessing strong technical writing skills, an in-depth understanding of ICH and FDA guidelines, and the ability to lead complex regulatory projects in a collaborative, matrixed environment.

The Director, Regulatory Affairs' responsibilities will be:

Shape and execute CMC strategies and regulatory submissions
Lead cross-functional collaborations to provide regulatory guidance
Participate in product teams, advising on CMC and regulatory compliance
Plan, author, and review strategic regulatory documents for submissions
Maintain awareness of evolving regulatory requirements and trends

Compensation:

$215,000 to $220,000 per annum.

If you're ready to make a meaningful impact in a role that challenges and rewards, we'd love to connect!

Reach out to Nicholas Walker at N.Walker@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.