Assoc. Spclst., Regulatory Affairs

Support activities related to specific short term projects.

• Contribute to the planning and execution of registration strategies for medicinal products in Singapore and Brunei to ensure timely and successful registration outcome.
• Assist with variation submissions and follow through with Regulatory Agency (Singapore and Brunei) until approval.
• Create artworks for variation submission and commercialization post Regulatory Agency approval in accordance with Singapore and Brunei regulations and internal procedures.
• Certificate of pharmaceutical product processing.
• Maintain and update internal regulatory affairs databases and systems.
• Support regulatory team with other administrative tasks.
• Manage document archival.
• Review for product listings for Zuellig and PV
• Support tender and renewal requirements and provide information/document support
• Support invoicing processing and SOP reviews.
• Involve in digital initiatives
• Clean up of archival documents, where necessary.

Required Skills

Adverse Event Report, Art Creation, Audits Compliance, Commercial Regulatory, Data Quality Assurance, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Pharmaceutical Manufacturing, Pharmaceutical Processing, Policy Implementation, Project Management, Records Retention Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Applications, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Management, Regulatory Strategy Development

Preferred Skills

Current Employees applyHERE

Current Contingent Workers applyHERE

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

Intern/Co-op (Fixed Term)

Relocation

VISA Sponsorship

Travel Requirements

Flexible Work Arrangements

Hybrid

Shift

Valid Driving License

Hazardous Material(s)

Job Posting End Date

07/23/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.

Requisition ID: R403483