Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
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 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
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html