Regulatory Affairs Manager (all genders) am Standort Ludwigshafen

☞ AbbVie

Ver: 178

Día de actualización: 24-10-2024

Ubicación: Ludwigshafen am Rhein Rhineland-Palatinate

Categoría: Legales / Contratos

Industria: Pharmaceuticals Biotechnology

Tipo de empleo: Full-time

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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

We are hiring!

Regulatory Affairs Manager (all genders)

Officebased Ludwigshafen

Overall Responsibilities

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

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

Main Accountabilities
  • Obtain marketing authorisations for new pharmaceutical products
  • Maintain marketing authorisations as required
  • Liaise with European Regulatory Affairs and Corporate groups on regulatory matters
  • Liaise with national regulatory authorities as required
  • Comply with the Company’s policies and procedures to assure 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
  • Liaise and attend meetings with other company functions to provide regulatory advice for new and existing products, including participation within affiliate Brand Team
  • Main responsibility for arrangement of national Scientific Advice with national Competent Authorities
  • Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements
  • Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable
  • Work closely with appropriate electronic systems and Label centers to get labels developed, approved, and implemented as per the required timeframe
  • Act as Information Qualified Person according to
  • 74a AMG (German Drug Law) and ensure that the labelling, the package leaflets and the expert information for HCPs (Fachinformation) correspond with the content of the marketing authorization. Review and approval of packaging materials in accordance with legislation and local procedures.
  • If required, coordinating the review of parallel import samples
  • Work closely with Supply chain in order to anticipate any back order of the products on the market
  • Ensure regulatory authority approval for new clinical trials and amendments to such trials undertaken by AbbVie in Germany
Qualifications

Required Education / Knowledge / Experience
  • Degree in Pharmacy, Life Sciences or similar
  • Fulfillment of requirements on Information Qualified Person in line with
  • 74a AMG
  • Very good understanding of national and European legal requirements for both medicinal products and medical devices
  • Experience of working in a regulatory environment
  • Good communication skills, both verbal and written
  • The ability to thrive in a changing environment and to re-prioritise workload to meet business needs
  • Good project management skills essential
  • Able to work under time pressure and set up priorities
  • Native German language skills
  • Very good English language skills
Travel

Yes, 10 % of the Time

Job Type

Experienced

Schedule

Full-time

Job Level Code

IC

Equal Employment Opportunity

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
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Plazo: 08-12-2024

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