Manager, CMC, Regulatory Affairs

Job Description

• Position title: Manager, CMC, Regulatory Affairs
• Department: Regulatory Affairs
• Report to: Associate Director of CMC
• Location: Beijing/Shanghai, China

Responsibilities

Take CMC lead for products under clinical development and for marketed drug products. Coordinate various aspects of CMC regulatory activities with internal and external stakeholders. Act as a primary representative internally and externally for CMC issues.

• Provide CMC expertise to support drug development at various stages including clinical trial application, NDA and post approval variations
• Lead the communication with HQ CMC and China RA teams to ensure high quality CMC submissions in compliance with China regulations and guidelines
• Act as a primary contact for CMC query response, lead and coordinate the response process between China and HQ teams, and interact with the agency for project related CMC issues
• Work with regulatory colleagues on specification, quality control testing and inspection for specific products; provide technical input and facilitate the discussion between China and HQ teams
• Participate in China project development teams to identify CMC needs by working with regulatory and project leads
• Develop network with pharmaceutical industrial associations and participate in CMC initiatives and task forces

Requirements

• BS, MS or PhD degree in chemistry, biology, or related scientific disciplines; Advanced degree is preferred.
• Expertise in CMC areas such as chemistry, formulation and analytical, 3~5 years of R&D and/or regulatory experience.
• Knowledge in CMC regulatory requirements and ICH guidelines.
• Good oral and written communication skills in both English and Chinese;
• Proactive and teamwork spirits

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

Visa Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(S):

n/a

Required Skills:

CMC Development, CMC Strategy, Communication, Detail-Oriented, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Strategies, Small Molecules

Preferred Skills:

Job Posting End Date:

12/31/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.