Job Description

Responsibilities

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 variationsLead the communication with HQ CMC and China RA teams to ensure high quality CMC submissions in compliance with China regulations and guidelinesAct 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 issuesWork with regulatory colleagues on specification, quality control testing and inspection for specific products; provide technical input and facilitate the discussion between China and HQ teamsParticipate in China project development teams to provide CMC regulatory assessment and strategy by working with regulatory and project leadsDevelop network with pharmaceutical industrial associations and participate in CMC initiatives and task forces

Requirements

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 6 years of R&D, manufacturing, 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.

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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:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

12/31/2025

*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.

Requisition ID:R337234