Associate Director, CMC

Job Description

Job Responsibilities

• Leadership and Team Management: Manage a team within China RA CMC including performance management training workload oversight and support for a healthy work-life balance. Ensure team activities are delivered effectively efficiently and in compliance with external regulatory requirements and internal quality procedures.

• Cross-functional Collaboration and Risk Management: Collaborate with departmental and cross-functional partners to share technical and regulatory knowledge align expectations coordinate planning and monitoring activities and mitigate risks.

• CMC Regulatory Submissions: Deliver timely and efficient CMC regulatory submissions across drug development and the lifecycle management.

• Technical Regulatory Support: Partner with regulatory colleagues on product specifications quality control testing and inspection-related matters; provide technical input and facilitate discussions between China and HQ teams.

• Project Team Engagement: Participate in China project development teams and work with regulatory and project leads to identify and address CMC needs.

• External Engagement: Build networks with pharmaceutical industry associations and participate in CMC initiatives and task forces.

Requirements

• BS 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 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;
• Proven ability in cross-functional cooperation alignment and ownership in problem solving;
• Experience in managing and coaching a high performing team.

Required Skills:

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.