Skip to main content

Search jobs

Search jobs

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.

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

change.

• 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

timeframe.

• 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
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

  • Quality Assurance, Ludwigshafen am Rhein, Rhineland-Palatinate, GermanyRemove

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation