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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.

Regulatory Affairs Labeling Manager (all genders) (unlimited / fulltime) in Ludwigshafen

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany Req ID 2209594 Category Quality Assurance Division AbbVie

• Work with the appropriate electronic systems soon after a new safety and

indication/efficacy information becomes available or the content of the CCDS may


• When approved, work closely with appropriate electronic systems (e.g. AMS) and

Label centers to get labels developed, approved and implemented as per the required


• Work closely with GLM in order to anticipate any back order of the products on the

market by ensuring artwork readiness.

• SmPCs: When approved, work closely with appropriate service provider (Rote Liste

GmbH) to have SmPCs developed, approved and published.

• Patient information leaflets for blind and partially sighted patients: When approved,

work closely with appropriate service provider (Rote Liste GmbH) to make suitable

leaflets available.

• Observe GMP rules for documentation in the described labeling processes.

• Where appropriate, activities to have information published in relevant drug

compendiums (e.g. Rote Liste, Gelbe Liste, Gelbe Liste Identa).

• Contribution to revision of labeling and other SOPs.

• Contact for labeling related audit questions.


Required Education / Knowledge / Experience

• Degree in Pharmacy, Life Sciences or similar

• Several years regulatory experience or in a related area in healthcare industry

• Project management and strategic communication

• Excellent German language skills at native level

• Good English language skills

Salary: The position is remunerated with Tarif E13K.

Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time

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