MSD Associate Specialist Regulatory Affairs 

Malaysia, Selangor 

91605036

Job Description

Regulatory Affairs Associate Specialist

• Opportunity to be a part of a global Regulatory Affairs organization in Malaysia!
• Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
• Join the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years .

Key Responsibilities:

• Handle regulatory activities throughout product life-cycle (product registration, post-approval variation, product renewals and company licenses) to meet local regulatory standards and submission timelines.
• Plan and assist in new submissions of product registration/ variation applications in close collaboration with regional and global team to ensure timely submission and approval.
• Interact and respond to local regulatory agencies’ enquiries to expedite approval of pending registrations.
• Prepare the Malay translation of English leaflet to align with Global labelling Product Information and local regulatory authority requirements for registration and importation, as applicable.
• Manage packaging materials of registered products to ensure timely implementation and compliance with relevant regulations/ registered details for import as well as company internal processes.
• Ensure correct and up-to-date regulatory documentation of databases.
• Keep up to date with Malaysia procedural requirements and legislation.
• Support regulatory team in communications, meetings, sample requests, artwork, etc.

Education Minimum Requirement:

• Graduates with Pharmacy degree or graduates with Science related degree eg. BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
  

Required Experience and Skills:

• 0-3 years’ experience in the Regulatory Affairs.
• Actively responsible and well-organized.
• Demonstrate ability to coordinate tasks with others and manage multiple tasks in a timely manner.
• Good communication and interpersonal skills, with good command in both written and spoken English and Bahasa Malaysia.
• Possesses computer literacy (MS Word, MS Excel, Internet, E-mail, PDF).
• Able to work across boundaries. Good collaboration with and communication to relevant stakeholders to complete tasks and projects.

Current Contingent Workers apply

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

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.