Senior Manager, Regulatory Affairs
Senior Manager, Regulatory Affairs
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Job Description
Job Description
Responsibilities:
- Work closely with Global colleagues to prepare dossiers and documents for product registration in China. Provide guidance and regulations required by the Chinese authorities for the documentation preparations. Independently undertake theproject.
- Work closely with internal colleagues in China to ensure that product registration in China is valuable and meets the requirements and timelines.
- Keep in touch with the Chinese authorities and agencies such as the MOA and theIVDC to track the registration process. If needed work with Global RA to prepare the answers to the questions.
- Interface and collaborate with the companys distributors and product importers in preparation and providing necessary documents and test results forsample and product import and product marketing.
- Assist the supervisor in problem solving preparation of study contracts and external services.
Requirements:
- MS degree Prevention Veterinary Medicine or equivalent;
- 7-8 years of direct regulatory affairs experience in veterinary products R&D QC QA CA technical support veterinary production preferred experience in veterinary registration for a foreign company. Especially registering one product or leaded one R&D project is much better;
- Professional and scientific interface established within both professional societies and animal health authorities;
- Fluent oral English
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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Adaptability Adaptability Audits Compliance Biological Sciences Business Communication Data Analysis Detail-Oriented Drug Regulatory Affairs Employee Training Programs Global Communications Leadership Management Process Negotiation Pharmaceutical Regulatory Affairs Pharmacovigilance Problem Solving Process Improvements Product Development Project Management Quality Management Quantitative Abilities Regulatory Affairs Compliance Regulatory Affairs Management Regulatory Compliance 5 morePreferred Skills:
Job Posting End Date:
09/30/2025*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:
Senior Manager
Employment Type
Full-Time
