Specialist, Regulatory Affairs

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

Additional location(s) 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
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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable
Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
11/30/2026 *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.