Akorn AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical (ophthalmic) sector and part of the Akorn Operating Company LLC, headquarter based in Gurnee, Illinois, USA. At Akorn AG, Hettlingen site (together with Winterthur site), high quality sterile products such as eye drops, ointments, otics, suspensions and gels are aseptically produced, filled and packed for international markets.

Regulatory Affairs Manager (m/f) 100 %

For our team in Hettlingen, we are looking for a Regulatory Affairs Manager and is responsible for the following main tasks:

Duties and responsibilities:
  • Responsible for implementing regulatory strategies, including filing of regulatory submissions to the health authorities for assigned projects and programs
  • Author, review and upkeep of quality-related and registration-related documents
  • Preparation of ANDA and post approval Submissions such as PAS, CBE-30, Annual Report and work closely with Global regulatory team
  • Maintain dossiers regulatory throughout the lifecycle and assist with internal optimization projects for commercial products as needed for the site according to priorities
  • Customer contact regarding registration-related questions
  • Compilation of documents and project performance for the preparation of registration and resolution of possible conflicts
  • Providing regulatory support and working closely with cross functional areas such as Quality, Supply Chain, Manufacturing and Product Transfer
  • Coordinate change control meetings and support in coordinating regulatory filing strategies both internally and with corporate, as needed
  • Overall submission support activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products
  • Archiving existing regulatory documents such as correspondence, submissions, approvals, deficiency letters and CTD sequence. to ensure they are current
  • Participate in project, regulatory, and launch meetings with flexibility to be available in company and sister site time zones as needed
  • Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team
Qualifications and requirements:
  • Completed apprenticeship or scientific degree in chemistry, pharmacy, biology or life science
  • At least 3 years of experience in the field of Regulatory Affairs in a cGMP environment (EU-GMP/FDA)
  • Good knowledge of regulatory requirements on the American and European markets
  • Experience in EU/ROW Submissions is an advantage
  • Experience and understanding in artwork/labelling is an advantage
  • Ideally, experience in dealing with JDE (material management system) and Veeva (document management system)
  • Excellent English knowledge required. German is desirable
  • Effective planning, organizational and interpersonal skills
  • Ability to work in a growing, fast-paced environment and adapt to resources and logistics as needed
  • Project management and time management skills to manage multiple ongoing projects simultaneously
  • Problem-solving ability, flexibility and values teamwork
We offer you an interesting and demanding job in a dynamic environment with a pleasant working atmosphere and attractive employment conditions.
Apply now!