Job Opportunity

Job Opportunity

Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

United States Posted 2025-08-19

Job Title: Senior Manager / Associate Director, Regulatory Affairs CMC
Location: Remote
Department: Regulatory Affairs CMC
Reports to: Director, Regulatory Affairs

Position Summary:

We are seeking a highly motivated and experienced Regulatory Affairs CMC professional to join our team at WuXi Biologics. This role will lead and execute global CMC regulatory strategies and ensure compliant and timely submissions for biologics and combination products (e.g., pre-filled syringes, autoinjectors, pen injectors). The ideal candidate brings a strong foundation in CMC regulatory affairs, with hands-on experience supporting the development and registration of biologics and drug-device combination products in global markets (U.S., EU, and others).

This role will serve as a key point of contact for regulatory CMC matters, supporting internal cross-functional teams and external clients in a fast-paced CDMO environment.

Key Responsibilities:

Serve as Regulatory CMC lead on project teams, acting as the primary liaison for clients and Health Authorities on Regulatory CMC and combination product topics.
Develop and implement global CMC regulatory strategies for biologics and combination products from early development through marketing applications and post-approval lifecycle management.
Lead the preparation, review, and submission of high-quality regulatory CMC documentation (INDs, BLAs/MAAs, IMPDs, amendments, briefing packages, etc.).
Guide regulatory strategy for combination products, ensuring alignment with evolving expectations for device constituent parts, human factors, design control, and EU MDR or FDA 21 CFR Part 4 compliance.
Represent Regulatory CMC in cross-functional internal and external project meetings, ensuring timely and strategic regulatory input across functions including Process Development, QA, Manufacturing, and Device Engineering.
Support Health Authority interactions, including preparation of briefing books, coordination of internal reviews, rehearsals, and response strategies.
Stay abreast of global regulatory trends and proactively assess their impact on current and future projects.
Support regulatory due diligence for new business opportunities and client proposals as needed.

Qualifications:

Education & Experience:

B.S. or higher in Life Sciences, Chemistry, Pharmacy, or related field; advanced degree (M.S., Ph.D., or Pharm.D.) preferred.
Minimum 10 years of industry experience in CMC, including at least 5 years in regulatory CMC for biologics.
Direct experience in developing and registering biologics and drug-device combination products such as pre-filled syringes, autoinjectors, or pen devices.
Successful participation in at least one major marketing application (BLA, MAA, etc.) required.
Prior CDMO experience is a plus but not required.

Technical Competencies:

Strong understanding of global regulatory requirements and guidelines for biologics, combination products, and device constituents.
Familiarity with ICH, FDA, EMA, and other international regulatory agency expectations.
Working knowledge of design control principles and device-related regulatory filings.
Excellent technical writing and project management skills.

Other Requirements:

Fluent in English; proficiency in Mandarin is a plus.
Excellent communication, collaboration, and interpersonal skills.
Ability to manage multiple projects with competing priorities in a matrix environment.

The anticipated pay for this position is $85,000-150,000

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertis and company business needs.

Apply now