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.