Regulatory Affairs Manager

Job description

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.