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 companys 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 companys 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 applyHERE
Current Contingent Workers applyHERE
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 dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.
Requisition ID: R424653