Regulatory Affairs Manager

Job Description

PRIMARY ACTIVITIES

1. <Primary activities 1>

• Prepare plan and set up process for filing new medicine applications and maintenance

of registration of existing company's 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's 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 .

Professional Competencies Required:

• 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.

Additional location(s) Compensation Information:

Required Skills:

Collaboration, Communication, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Compliance, Regulatory Strategy Development

Preferred 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: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 12/2/2026

*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.