REGULATORY MANAGER

MCR International | Executive Search

Responsibilities

- Provide regulatory advice and support to the organisation on the content of existing marketing authorisations and for products in development phase.
- Provide general regulatory advice and support to other departments.
- Review and approve promotional and non‑promotional material to comply with local regulation, self‑regulations and internal policies and procedures. Advise the marketing teams on the promotional activities.
- Support pharmacovigilance department on safety relevant matters in line with national requirements.
- Support the Head of RA with developing and meeting the longer‑term goals for the department.

Main Accountabilities

- Obtain marketing authorisations for new pharmaceutical products, working closely with area headquarters.
- Maintain marketing authorisations as required.
- Review of promotional and non‑promotional materials and activities in accordance with legislation, local procedures and codes of practice.
- Regulatory advice and support to Brand Team on promotional materials content and activities.
- Keep updated in current regulations in promotion of medicines and in Spanish Code of Practice for the Pharmaceutical Industry.
- Liaise and attend meetings with other company functions to provide regulatory advice for new and existing products; participation in affiliate Brand Teams regarding regulatory strategies and proposed label changes, to provide regulatory advice for new and existing products.
- Provide regulatory support for the Brand Teams commercial divisions in all areas pertaining to product life‑cycle management and new product development.
- Liaise with European Regulatory Affairs and Corporate groups on regulatory matters.
- Liaise with national regulatory authorities as required.




- Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.
- Comply with the Company’s policies and procedures to ensure consistency of the current local prescribing information with the CCDS in order to: Ensure alignment within the organization.
- Meet the expectations of regulatory agencies.
- Implement approved label through defined artwork process.
- Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable.
- Ensure compliance with all relevant statutory requirements and all relevant internal procedures.
- Represent affiliate regulatory position at defined initiatives or projects from general or area.
- Reviews and is updated in the industry environment (e.g. regulatory, legal, EFPIA and local codes) and provides regulatory position, perspective and expertise related to advertising and promotion to business partners.
- Support audits and inspections.
- Keeps and maintains regulatory operation processes and systems to support regulatory submissions and approvals in the most efficient.
- Keeps and manages product registration databases to ensure information transmission timely and accurately.

Qualifications

- Degree in Pharmacy, Life Sciences or similar.
- 10 years of experience in Regulatory Affairs.
- Strong knowledge of regulations, and special focus on expertise on regulation of promotion and the Farmaindustria Code of Practice.
- Project Management and Strategic Communication.
- The ability to thrive in a changing environment and to re‑prioritise workload to meet business needs.
- Strong negotiation skills to build consensus.

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Other

Industry

Pharmaceutical Manufacturing

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📌 REGULATORY MANAGER (Madrid)
🏢 MCR International | Executive Search
📍 Madrid