Regulatory Affairs Manager

Job Description

To ensure timely product registrations that are in compliance with related regulatory requirements.

Managing well all projects on registration and maintaining license of products for sporting business.

PRIMARY ACTIVITIES

1. Primary activities 1

• Prepare plan and set up process for filing new medicine applications and maintenance of registration of existing company products with regulatory authorities in timeline required.

• Notify regulatory authorities of changes to medicines.

• Maintain the process for update label based on requirement of Global for products responsible the monitoring of packaging and labeling.

• Assist in the monitoring of PV system if any.

• Assist for Product quality control together with SCM Team if any.

2. Primary activities 2

• Obtain regulatory approval within optimum timelines and subsequently ensure new products are made accessible in the fastest time possible.

• Ensure immediate regulatory authority notification in relation to medicine changes.

• Help to maintain high quality and accurate packaging and labelling of company products.

• Develop and implement time and cost saving initiatives for this role.

• Develop and implement services to assist in delivering better value to customers.

• Specific measures as per personal performance grid.

• Good collaboration with other function team for supporting business.

Desired Experience/Education:

• University graduate major in medicine/pharmacy

• Prior experience in the pharmaceutical industry at least 3 years .

• Familiar with policies and procedures of Ministry of Health.

• Good working knowledge of applicable Laws and Regulations.

• Relevant knowledge of the health industry.

• Relevant knowledge of products and options.

• Competent in English language.

Required Skills:

Accountability, Accountability, Adaptability, Audits Compliance, Business Management, Business Strategies, Delivering Value, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, English Language, Global Communications, Manufacturing Compliance, Mentorship, Motivation Management, Pharmaceutical Management, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Process Planning, Project Management, Quality Control Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Management {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/31/2025

*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.