Regulatory Affairs Manager

MFC- 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.

• 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.

• 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.