Regulatory Affairs Manager
Regulatory Affairs Manager
Posted on :
25-07-2025
Employer Active
1 Vacancy
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Job Description
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 Companys 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
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
Key Skills
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