MSD Regulatory Affairs Specialist 

Serbia, Central Serbia, Stari Grad Urban Municipality 

258655945

Job Description

Basic Functions & Responsibility(may not be limited to):

• For assigned products and under supervision of Country Lead/Associate Director ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities.
• For assigned products and under supervision of Country Lead/Associate Director ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• For assigned products ensures timely, accurate and compliant labelling translations and artwork preparation.
• For assigned products and tasks, stays updated on relevant EU and 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. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
• By discretion of Regulatory Affairs Management and due to organization and workload, all listed activities need not to be performed.

Major Activities(may not be limited to):

New MA applications for assigned products

• Under supervision, performs timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing and external affairs departments 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 communicates approvals to stakeholders through the correct processes.

Compliance

• For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to company and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
• Ensures that all internal customers receive relevant information regarding 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 Agency requirements and in-house guidance.

Labelling and artwork

• Provides high quality translations and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents.
• Prepares artwork, including package leaflets and all other components in timely and correct manner and according to relevant Artwork Management procedures.
• The above-mentioned tasks are performed under supervision of Country Lead/Associate Director Regulatory Affairs as well as Regulatory Affairs International, Global Labelling, Regulatory Affairs Europe.

Cross-functional activities

• Secures timely and adequate information and decision making with regard 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.

Regulatory policy & environment

• Keeps abreast of local and international laws.
• Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization, and other stakeholders, and in concurrence with the EU Regulatory Policy lead.

Qualifications, Skills & Experience

• Must be at least B.Sc. in pharmacy or other life science or equivalent.
• An approx. minimum of 2 years’ experience in the pharmaceutical Industry is preferable, in a regulatory, medical or laboratory position.
• Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.
• The incumbent should possess a 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 local and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.
• For seniority, an approx. minimum of 2 years’ experience in a Registration Department, dealing with most aspects of registration, with sufficient working knowledge of the subject area to require minimal supervision from the Manager.
• A sound appreciation of the interactions and relationships of the dept with other groups internally is expected.

Current Contingent Workers apply

Not Indicated

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