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.
(Junior) Project Manager Regulatory Affairs (all genders) - (unlimited / fulltime)
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany Req ID 2210848 Category Regulatory Affairs Division AbbVie- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- 3 year working experience with a minimum of 2 years experience required in Regulatory, R&D or related area
- Minimum of 1 years experience preferred in pharmaceutical regulatory affairs.
- Having experience interfacing with government regulatory agencies and proven skill at developing and implementing successful China regulatory strategies.
- Biologics experience a plus. Experience in Gastro, Liver, CV, Urology, CNS, Vaccine, etc. is a plus
- Fluent English both oral and written
- Working Computer Operation skill
- Is willing to travel
- Experience working in a complex and matrixed environment is requiredDependent on individual aptitude
- Up to date knowledge of legislation
- Self motivated
Most recent jobs
Explore our open jobs and find your perfect fit.
- San Francisco, California Specialty Representative, Migraine - San Francisco/Peninsula, CA Req ID: 2119891 Category: Sales Division: AbbVie Learn more about Specialty Representative, Migraine - San Francisco/Peninsula, CA
- Vienna, Vienna MSL Req ID: 2120911 Category: Medical Division: AbbVie Learn more about MSL
- Westport, Connaught Technical Lead (Pharmaceutical Small Molecule) / Senior Specialist Req ID: 2200018 Category: Manufacturing & Operations Division: AbbVie Learn more about Technical Lead (Pharmaceutical Small Molecule) / Senior Specialist
- Ludwigshafen am Rhein, Rhineland-Palatinate Principal Platform Business System Owner (all genders) - (unlimited / fulltime) Req ID: 2120963 Category: Information Technology Division: AbbVie Learn more about Principal Platform Business System Owner (all genders) - (unlimited / fulltime)
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