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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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Manager Regulatory Affairs (all genders) - (unlimited / fulltime)

Ludwigshafen am Rhein, Germany Req ID 2204600 Category Regulatory Affairs Division AbbVie

Overall responsibilities

  • To provide Regulatory advice and support to other departments
  • Manage and develop a team
  • Define the priorities in collaboration with the Director RA
  • To support the Director RA with budget planning, developing and meeting the longer-term goals for the department
  • Support pharmacovigilance department on safety relevant matters in line with national requirements
  • Information Qualified Person according to §74a AMG (German Drug Law)/Informationsbeauftrage(r)

Main Accountabilities

  • Provide line management for defined members of the department including:
  • Set goals and development plan
  • Review working practices and task performed
  • Conduct performance appraisals
  • Recruit permanent/contract staff, where appropriate
  • Planning of regulatory and quality activities


  • Approve expenses and invoices
  • Liaise with external authorities/organisations as required
  • Liaise with European Regulatory and Corporate groups
  • Ensure compliance with all relevant statutory requirements and all relevant internal procedures
  • Keep track of regulatory developments, new guidelines
  • Review and approve local regulatory (and quality) procedures in line with global procedures
  • Represent affiliate regulatory position at defined initiatives or projects from global or area
  • Ensure training to RA and other affiliate personnel regarding relevant Regulatory Affairs related local procedures.
  • Act as deputy to the Director Regulatory Affairs as required


  • Ensure participation of RA personnel in Brand teams and internal discussions regarding regulatory strategies and proposed label changes, to provide regulatory advice for new and existing products
  • Provide regulatory support for the commercial divisions in all areas pertaining to product life-cycle management and new product development and introduction
  • Act as member of the Affiliate Risk Management Team (ARMT)
  • Ensure the review of all submissions to the authority
  • Ensure regulatory authority approval for named patient and compassionate use trials and amendments to such trials undertaken by AbbVie in Germany, as required



Information Qualified Person according to § 74a AMG (German Drug Law)

Overall Responsibilities

Promotional and non-promotional material activities for the affiliate from regulatory perspective

Review and approval of promotional and non-promotional material to comply with local regulation, self-regulations and internal policies and procedures


  • Functions as a subject matter expert both within Regulatory advertising and promotion and related functional areas
  • Directs, influence and implements local regulatory policy and procedures based on global policies
  • Serves as strategic regulatory promotional partner to Brand Teams both pre-approval and post approval and on key initiatives
  • Reviews and evaluates the industry environment (e.g. regulatory, legal, EFPIA and local codes) and plans strategically for providing regulatory position, perspective and expertise related to advertising and promotion to internal and external business partners

Required Education / Knowledge / Experience

  • Life sciences degree (e.g. Pharmacy)
  • Extended experience in Regulatory Affairs
  • Experience in managing/leading a team of people
  • Excellent communication skills
  • Excellent German and English language skills  
  • Strong interest on development within regulatory affairs and on leadership
Travel: Yes, 20 % of the Time
Job Type: Experienced
Schedule: Full-time

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  • Regulatory Affairs, Ludwigshafen am Rhein, Rhineland-Palatinate, GermanyRemove

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