Come join our team

Galenicum is a growing company. We believe that our dedicated team is vital to our current and future success. Our HR department is always looking for new candidates-collaborators-workers to fill positions in a variety of areas. If you are interested in working with us, please send a cover letter along with your CV to:

recruiting@galenicum.com

Job Offers

REGULATORY AFFAIRS EXPERT

REGULATORY AFFAIRS EXPERT

March 22, 2013

Position in organization:

 

Department: Regulatory Affairs

Reporting to: Regulatory Affairs Manager

Staff in charge: -

Location: Barcelona Headquarters

Education / experience:

 
  • Bachelor's degree in Medicine or Pharmacy
  • Master's degree in Regulatory Affairs or/and Monotoring Clinical Trials or/and Pharmacovigilance.
  • Excellent level of scientific and business English, spoken and written.
  • Excellent computer skills

Previous experience required:

 

Minimum 2 years' experience in the area of registration of medicines for human use, preferably generic drugs. Very valuable to have experience and knowledge in Pharmacovigilance and Clinical Trials. 

Roles and responsibilities:

 
  • Compilation, evaluation and submission of registration dossiers to local and international regulatory agencies, of Galenicum developed products and licensing from other companies.
  • Support in developing and writing clear arguments and explanations for new product licences and licence renewals.
  • Monotoring, updating and adapting documents, preparing submissions of licence variations and renewals to strict deadlines. 
  • Pricing and reimbursement.
  • Maintenance of approved dossiers.
  • Management of documentation and requirements for providing APIs to customers.
  • Compilation and evaluation of DMF.
  • Be updated of the regulatory requirements ( international legislation, guidelines and customer practices) and registration procedures in all the company's export markets.
  • Regulatory support to various departments of the company, specially with regard to new development products.
  • Management and development of registration documentation related to manufacturing transfer for customers.
  • Variations and periodic safety  update reports and renewals (pharmacovigilance). Pharmacovigilance management. 
  • Writing clear, accesible product labels and patient information leaflets. 
  • Management and monotoring of clinical trials. Coordinating and following ethical, regulatory and contractual topics of the trials. Following the design and phases of all clinical trials. 

Personal Profile:

 
  • Highly disciplined, responsible, methodical, resolutive and organised individual. 
  • Excellent oral and written communication and interpersonal skills.
  • Strong attention to detail and analytical frame of mind.
  • Capable to work under pressure under your own initiative whilst being a good team player.