Specialist, Regulatory Affairs

Merck; Petaling Jaya; On-site; MYR 120,000 - 180,000; Full time

Job summary

Merck is seeking a Regulatory Affairs professional to support timely preparation, submission, and follow-up of new Marketing Authorization applications to local authorities, under the supervision of the Associate Director.

The role also covers maintenance activities for assigned products, including variations, renewals, and supplementary approvals, with a focus on ensuring compliant labeling translation, artwork management, and ongoing regulatory liaison to health authorities.

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.

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/o