Sr. Specialist, Regulatory Affairs

Job Description

Responsibilities:

• Collaborate closely with global colleagues to prepare dossiers for veterinary medicine product registration in China (e.g., variations, renewals, GMO applications), providing guidance on Chinese regulatory requirements and conducting regulatory assessments.
• Support regulatory affairs operations, including but not limited to artwork management and pharmacovigilance, to ensure compliance with regulations and company policies.
• Communicate effectively with authority and internal stakeholders to ensure product registrations in China meet all requirements and deadlines.
• Maintain regular contact with Chinese authorities and agencies such as MARA, IVDC, and China Customs to monitor registration progress; coordinate with global colleagues to respond to questions as needed.
• Interface and collaborate with the company’s distributors and importation agencies to prepare and provide necessary documentation for sample importation and product marketing.
• Assist the supervisor in problem solving and related tasks.

Requirements:

• MS degree or higher with preventive veterinary medicine, veterinary medicine, clinical veterinary, pharmaceutical, biopharmaceutical related fields.
• Minimum of 3 years’ direct regulatory affairs experience in veterinary or human health products, R&D, QA, BTS or related areas.
• Demonstrate ability in problem-solving and agility to drive excellence.
• Good oral and written communication skills in both English and Chinese.

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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Adverse Event Report, Adverse Event Report, Audits Compliance, Business, Business Assistance, Communication, Data Analysis, Data Quality Assurance, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Leadership, Management Process, Negotiation, Policy Implementation, Problem Solving, Quality Management, Quantitative Abilities, Records Retention Management, Regulatory Affairs Compliance, Regulatory Applications, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Strategy Development {+ 3 more}

Preferred Skills:

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:R355900