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](https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) **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.**