Manager, CMC, Regulatory Affairs

Beijing - China

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 35 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

Search Firm Representatives Please Read Carefully
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:

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

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 BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Required Experience:

Manager

Job DescriptionPosition title: Manager CMC Regulatory AffairsDepartment: Regulatory AffairsReport to: Associate Director of CMCLocation: Beijing/Shanghai ChinaResponsibilitiesTake CMC lead for products under clinical development and for marketed drug products. Coordinate various aspects of CMC regul...