REGULATORY AFFAIRS MANAGER

MFC-2510-344

REGULATORY AFFAIRS MANAGER

MADRID

Overall responsibilities

To provide regulatory advice and support to the organisation on the content of existing marketing authorisations and for products in development phase.

To provide general regulatory advice and support to other departments.

Review and approval of promotional and non-promotional material to comply with local regulation, self-regulations and internal policies and procedures. To advice the marketing teams on the promotional activities.

Support pharmacovigilance department on safety relevant matters in line with national requirements.

To support the Head of RA with developing and meeting the longer-term goals for the department.

Main Accountabilities

Obtain marketing authorizations for new pharmaceutical products, working closely with area headquarters.

Maintain marketing authorizations 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 global 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.

Fluent English language skills.

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