Associate Regulatory Affairs Manager
Content + Source + Freshness • 12 Dec 2025 • 95% confidence
Offer value
Position offers a vital regulatory role in a specialized biotech industry with a niche focus on ophthalmology.
- Opportunity to impact biotech regulatory processes
- Engagement in specialized industry with room for growth
- Requires niche expertise which may affect candidate availability
Pros
- Opportunity to work in a innovative biotech industry
- Independently manage significant regulatory tasks
- Role conducive to developing specialized regulatory expertise
Cons
- Less clarity on compensation structure and package
- Requires niche experience that may limit candidate pool
- Work may involve stressful regulatory compliance tasks
Who it's for
Mid-level • On-site, potentially hybrid
Good fit
- Mid-level professionals in regulatory affairs
- Candidates with interest in biotechnology
- Individuals seeking to deepen knowledge in compliance
Not recommended for
- Entry-level candidates in search of broad roles
- Those not willing to engage in detailed regulatory documentation
- Individuals seeking less compliance-focused careers
Motivation fit
Key skills
About the job
Job Description
Job Overview
Under local regulatory requirements and responsible for all new product registration including new claims and licenses extension/renewal, to support business growth and business continuity, in compliance with local laws, regulations, guidelines and the company's policies & SOPs
Primary Accountabilities/Responsibilities
1. Under the general direction of supervisor, independently perform product registration including new product licensing and maintenance of existing product registration and renewals.
2. Compile registration dossier and prepare other regulatory documents (e.g., local package inserts, packaging components) and ensure timely regulatory submission under internal review and approval.
3. Support potential manufacturing site transfer and/or Marketing Authorization transfer from legal regulatory owner to the company and maintain licenses in the markets through renewals and product variations for all company products.
4. Support the progress of the registration projects by coordinating with the company’s internal departments (e.g. IRIS, Alexx, RTT, Reliance..etc)
5. Support the sampling process per commercial batches and work with Zuellig Pharma for tender operation.
6. Communicate and build relationship with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
7. Input and properly maintain all regulatory and legal documentation.
8. Collect internal and external regulatory and competitive information and report to supervisor.
9. Establish and maintain general understanding and knowledge of regulatory requirements, regulatory SOPs and other functional systems.
10. Assist in Quality affairs projects and procedures that are related to regulatory affairs.
11. Assist in any other regulatory tasks as assigned.
12. Coordinate the execution of local development and/or post marketing studies when applied.
Qualifications, Skills & Knowledge
- Prefer bachelor degree in science or animal science.
- At least 3-5 years’ experience in Veterinary Medicine/Pharmaceutical Company regulatory affairs.
- Sound Knowledge of Taiwan regulatory processes and requirements.
- Good communication skills in English
- Excellent interpersonal skills to handle sensitive and confidential information/situations and able to network effectively across groups and levels.
- Able to work independently
- Able to work under pressure and compliance with deadlines.
Other Information
Able to travel to meet business commitments where required.
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Ability to Work Under Pressure, Ability to Work Under Pressure, Adaptability, Animal Science, Business, Business Administration, Business Continuity, Business Management, Business Operations, Communication, Detail-Oriented, Drug Registration, Electronic Common Technical Document (eCTD), Employee Training Programs, In Licensing, Interpersonal Communication, Licensing Law, Management Process, Manufacturing Compliance, Mentorship, New Product Qualification, Packaging Processes, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Pressure Management {+ 18 more}Preferred Skills:
Job Posting End Date:
07/31/2025*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.
