Sr. Specialist, Regulatory Affairs
Sr. Specialist, Regulatory Affairs
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Job Description
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 companys 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Business Communication Data Quality Assurance Document Control Systems Problem Solving Quality Management Regulatory Communications Regulatory Compliance Strategic Thinking Task CoordinationPreferred Skills:
Pharmaceutical IndustryJob 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:
Senior IC
Employment Type
Full-Time
