Merck & Co., Inc. / Merck Sharp & Dohme LLC is looking for a Senior CMC Regulatory Affairs Expert to take the CMC lead for products in clinical development and for marketed drug products. You will coordinate various CMC regulatory activities with internal and external stakeholders 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 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 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.
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 spirits.
Nice to Have
- An advanced degree is preferred.
Team & Environment
This role sits within the Regulatory Affairs department and reports to the Sr Manager of CMC.
Work Mode
This is an onsite position located in Beijing or Shanghai, China.
Merck & Co., Inc. / Merck Sharp & Dohme LLC is an equal opportunity employer.
