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:
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.
- 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.