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
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BS, MS, or PhD degree in chemistry, biology, or related scientific disciplines; an advanced degree is preferred.
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Expertise in CMC areas such as chemistry, formulation, and analytical, 3~5 years of R&D and/or regulatory experience.
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Knowledge of CMC regulatory requirements and ICH guidelines.
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Good oral and written communication skills in both English and Chinese;
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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.