Sr. Manager, CMC, Regulatory Affairs
Sr. Manager, CMC, Regulatory Affairs
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Job Description
Job Description
Position title: Senior Manager Regulatory Affairs CMC
Department: Regulatory Affairs
Report to: Associate Director Regulatory Affairs CMC
Location: Beijing China
Responsibilities
Lead Regulatory CMC Policy & Intelligence efforts to effectively navigate the regulatory landscape advocate for CMC policies and contribute to achieving strategic policy objectives.
- Develop and implement CMC policy strategies ensuring alignment with regulatory requirements and organizational goals.
- Develop clear and persuasive CMC regulatory positions on relevant issues in collaboration with global local and external stakeholders including industry associations etc.
- Engage proactively with the Health Authorities (HA) industry associations advocacy groups and other external partners to establish our companys voice and leadership in task forces meetings and advocacy efforts.
- Establish and maintain robust internal policy network to drive coordinated influence strategies.
- Ensure organizational awareness alignment and implementation of relevant CMC policy requirements between global and China teams.
- Closely monitor manage triage and archive regulatory CMC requirements and guidance documents. Lead the preparation of insightful comments on draft regulations guidance and other policy documents.
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 provide CMC regulatory assessment and strategy by working with regulatory and project leads
- Develop 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.
- In-depth knowledge of CMC regulatory requirements and ICH guidelines deep understanding of the regulatory science and expectations.
- Proven experience of managing dynamic cross-functional projects and initiatives which requires great collaboration engagement and knowledge sharing
- Strong leadership communication and organizational skills with the ability to influence engage stakeholders both internally and externally
- Excellent oral and written communication skills in both English and Chinese including presentation skills.
- 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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
CMC Documentation CMC Strategy Communication Interpersonal Relationships Regulatory Affairs Compliance Regulatory Affairs Management Regulatory CMC Regulatory Policies Regulatory Strategy DevelopmentPreferred Skills:
Job Posting End Date:
12/31/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Manager
Employment Type
Full-Time
