Regulatory Affairs Manager

Job Description

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.
• 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.