Specialist, Regulatory Affairs

MSD; Petaling Jaya; On-site; MYR 70,000 - 110,000; Full time

Job summary

MSD Malaysia is seeking a Regulatory Affairs professional to manage MA applications, variations, and labeling artwork under supervision. You will liaise with local authorities and internal teams to ensure timely approvals and lifecycle management.

The role requires a Bachelor's in Pharmacy or Life Science, strong communication and organizational skills, and proficiency with digital tools, including AI literacy. You will work with GRACS regions and QA/Medical Affairs to support compliance.

Qualifications

• 2+ years of experience in regulatory/medical/lab roles preferred.
• Bachelor's Degree in Pharmacy or Life Science required.
• Strong verbal and written communication, organization, and planning skills.
• Proficiency with digital workplace tools (word processing, spreadsheets, databases, collaboration tools) and AI literacy.

Responsibilities

• Prepare, submit and follow up MA applications with local authorities under supervision.
• Maintain licenses via variations and renewals with timely submissions.
• Translate and QA local PI/RiMUP and ensure accurate labeling components.
• Support regulatory interactions with health authorities for approvals and lifecycle management.
• Collaborate with QRP, Medical Affairs and PV to ensure compliance and quality.

Skills

Communication

Attention to detail

Organizational skills

Planning

Digital literacy

AI literacy

Teamwork

Education

Bachelor's Degree in Pharmacy or Life Science

Job description

Job Description At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and contribute to our mission of making a difference in global health.

WHAT YOU WILL DO

• For assigned products and under supervision of Associate Director ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to local authorities.
• For assigned products and under supervision of Associate Director ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• For assigned products ensures high quality labelling translation and artwork management.
• Supports local health authorities interactions to ensure seamless submission, assessment, and quick approval of Market Authorizations and lifecycle management applications.
• For assigned products and tasks, stays updated on relevant local regulations and guidelines.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• Maintains a positive relationship with internal and external regulatory contacts.
• GRACS on sub-regional, regional and global level, Medical Affairs and GSC&PV are the main contact points within the company.
• External contacts are regulatory authorities, as well as other key players in the regulatory environment.

Major Activities (may not be limited to):

New Marketing Authorization (MA) Applications for Assigned Products

Under supervision, performs timely and correct submissions and approvals of assigned new Marketing Authorization applications in close cooperation with relevant person in the managing, medical, marketing departments, GRACS on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type. Tracks process on products registration and major new indications.

Maintenance of Licenses for Assigned Products

Under supervision, ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicate approvals to stakeholders through the correct processes.

Compliance

For assigned products, ensures timely preparation and maintenance of local Package Insert (PI) and/or Consumer Medication Information Leaflet (RiMUP), packaging material and other applicable regulatory documents according to company and local standards and relevant Artwork Management procedures. Implement the relevant labeling components within the correct timeframes for compliance. Ensures that all internal stakeholders receive relevant information with regards to the regulatory status of the assigned products. Ensures the correct and proper utilization of Artwork Management System to generate mock-up artwork and to implement revisions to artwork. Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country. Ensures that files and archives related to Regulatory are kept updated and complete. Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with. Participates in implementation of updated regulatory documentation according to regulatory authorities requirements and in-house guidance. Contributes regulatory support during internal audits and/or health authority inspections.

Editing and Labelling

In connection with submission of MA applications and post-approval submissions, provides translation and check of local PI and/or RiMUP and ensures quality assurance including linguistic check of these documents. The above-mentioned tasks are performed under supervision of Associate Director as well as Regulatory Affairs International and Global Labelling.

Artwork

Prepares artwork, including PI and all other components in a timely and correct manner and according to relevant Artwork Management procedures. The incumbent ensures proof reading of packaging components and is responsible for maintaining an updated file on packaging components, as applicable.

Cross-Functional Activities, as Assigned

Secures timely and adequate information and decision making with regards to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions. Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice. Adequately supports other functions to enable compliance in areas related to regulatory, such as providing the RA inputs and/or assessments related to PV or local importation activities. Ensures handling of customer complaints and support product recalls activities according to company standards and local procedure. Closely cooperates with Quality Responsible Person (QRP), Medical Affairs and/or Pharmacovigilance where applicable. Under supervision by QRP performs assigned tasks regarding product quality and safety according to local requirements.

Regulatory Policy & Environment

Keeps abreast of local and international laws. Through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with company interests. Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with the Country Regulatory Affairs Lead. Participates in internal Asia Pacific regulatory workgroups on selected issues, as assigned.

QUALIFICATIONS, SKILLS & EXPERIENCE

A minimum of 2 years' experience in the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position. Must be at least a Bachelor's Degree in Pharmacy or other Life Science or equivalent. Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills. The incumbent should possess meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work. Must be able to work both alone and as part of a team and have the ability to concentrate on large volumes of written/paper-based work in an office environment. The incumbent must demonstrate proficiency in digital workplace technologies, including word processing, spreadsheets, databases, internet-based applications, and collaboration tools. The incumbent is also expected to demonstrate digital and AI literacy, including the responsible and effective use of enterprise-approved AI-enabled and productivity tools to support job-related activities and improve efficiency in compliance with company policies and applicable regulations. For seniority, a minimum of 2 years' experience in a Registration Department, dealing with most aspects of registration, with sufficient working knowledge of the subject area. A sound appreciation of the interactions and relationships of the department with other groups internally is expected.

Key Enterprise Leadership Behaviours

• Execution Excellence
• Ownership & Accountability
• Change Catalyst

Compensation Information: Required Skills: Communication, Detail-Oriented, Pharmaceutical Sciences, Regulatory Approvals, Regulatory Experience, Regulatory Filings, Regulatory Work, Results-Oriented, Self Motivation, Teamwork. Preferred Skills: Analytical Thinking, Innovation, International Regulatory Compliance, Regulatory Policies

Employee Status: RegularRelocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not ApplicableShift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/30/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.