Merck & Co., Inc. / Merck Sharp & Dohme LLC is seeking a Manager, CMC to take the lead on Chemistry, Manufacturing, and Controls for products under clinical development and marketed drug products. In this role, you will coordinate CMC regulatory activities and act as a primary representative for CMC issues.
What You'll Do
- Provide CMC expertise to support drug development at various stages including clinical trial application, NDA and post approval variations.
- Lead communication with HQ CMC and China RA teams to ensure high quality CMC submissions compliant 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 regulatory agencies.
- Work with regulatory colleagues on specification, quality control testing and inspection for specific products; provide technical input and facilitate discussions between teams.
- Participate in China project development teams to identify CMC needs by working with regulatory and project leads.
- Develop a network with pharmaceutical industrial associations and participate in CMC initiatives and task forces.
What We're Looking For
- BS, MS or PhD degree in chemistry, biology, or related scientific disciplines.
- Expertise in CMC areas such as chemistry, formulation and analytical, with 3~5 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.
- Proactive and teamwork-oriented approach.
Nice to Have
- An advanced degree is preferred.
Team & Environment
This role is within the Regulatory Affairs department and reports to the Senior Manager of CMC.
Work Mode
This is a local-city role located in Beijing or Shanghai, China.
Merck & Co., Inc. / Merck Sharp & Dohme LLC is an equal opportunity employer.
