(Asso.) Manager, CMC RA

Job description

Job Description 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; an 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 of CMC regulatory requirements and ICH guidelines. Good oral and written communication skills in both English and Chinese; Proactive and teamwork spirits Required Skills: Clinical Development, Document Coordination, Drug Development, Drug Formulations, Interpersonal Relationships, Pharmaceutical Manufacturing, Regulatory CMC, Regulatory Communications, Regulatory Documents, Regulatory Operations, Regulatory Strategies 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.