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\xe2\x80\x99 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\xe2\x80\x99 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.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySearch 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:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 07/19/2024*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.

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