Associate Director, CMC

Job Description

Job Responsibilities

• Leadership and Team Management: Manage a team within China RA CMC, including performance management, training, workload oversight, and support for a healthy work-life balance. Ensure team activities are delivered effectively, efficiently, and in compliance with external regulatory requirements and internal quality procedures.

• Cross-functional Collaboration and Risk Management: Collaborate with departmental and cross-functional partners to share technical and regulatory knowledge, align expectations, coordinate planning and monitoring activities, and mitigate risks.

• CMC Regulatory Submissions: Deliver timely and efficient CMC regulatory submissions across drug development and the lifecycle management.

• Technical Regulatory Support: Partner with regulatory colleagues on product specifications, quality control testing, and inspection-related matters; provide technical input and facilitate discussions between China and HQ teams.

• Project Team Engagement: Participate in China project development teams and work with regulatory and project leads to identify and address CMC needs.

• External Engagement: Build networks with pharmaceutical industry 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, at least 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;

• Proven ability in cross-functional cooperation, alignment and ownership in problem solving;

• Experience in managing and coaching a high performing team.

Required Skills:
CMC Development, CMC Strategy, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking, Team Management, Vendor Management
Preferred Skills:

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:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
12/31/2026*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.