Regulatory Affairs Specialist

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

• For assigned products ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities as applicable.

• For assigned products 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 the agency interactions to ensure a seamless submission, assessment, and quick approval in cooperation with other internal stakeholders.

• 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.

• Under supervision, performs timely and correct submissions and approvals of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing, external affairs departments, outcomes research, our Manufacturing Division, 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.

• 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 time frames and communicate approvals to stakeholders through the correct processes.

• 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 our company and local standards and relevant Artwork Management procedures. Implement Prescribing Information within the correct time frames for compliance.

• Ensures that all internal customers receive relevant information with regard 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 Agency requirements and in-house guidance.

• In connection with submission of MA applications and post-approval submissions provides translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and ensures quality assurance including linguistic check of these documents.

• Prepares artwork, including package leaflets 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.

• 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.

• Adequately supports other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.

• 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 our company's interests.

• 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.

• Participates…