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RA Associate Specialist

3 months ago

Bangkok, Bangkok, Thailand MSD Full time

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies.

We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world.

  • Coordinates regulatory activities in Thailand.
  • Manage submissions and interactions with Thai regulatory agencies.
  • To be communicator from regional requirements and ensure compliance with all the required regulations for assigned projects.
  • Coordinate or oversee preparation of regulatory documentation in a timely manner to meet corporate objectives.
  • Work cross-functionally and collaborate with other either regional or within country to achieve regulatory affairs objectives

Primary activities include, but are not limited to:

  • Handle regulatory submission and approval procedures of new drugs and generic drugs.
  • Effectively communicate with Regional and Global Regulatory Affairs in the responsible product areas including system compliance and product packaging.
  • Interact with local health authority in regulatory issues and keep long term relationship with key authority.
  • Act as a focal point for regulatory information and consultation in the responsible product areas for internal and external parties.
  • Maintain up-to-date knowledge at all time with applicable rules and regulations Ensure compliances with applicable laws and regulations including company policies

To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:

  • Bachelor's Degree in Pharmacy
  • 1-2 years experiences in ACTD/ACTR registration procedures of new drugs and generic drugs.
  • Actively Responsible, hard-working, well-organized
  • Good communication (both written and spoken English)
  • Good judgment and problem-solving skills
  • Good technical and professional knowledge, including computer skills

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/5/2024

*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.

Job Posting End Date:08/05/2024

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:R305989