Regulatory Affairs
B2C Expert

Date: --
Ref: JD-089.01

Position in organization

  • Department: Regulatory Affairs
  • Reporting to: Regulatory Affairs Manager
  • Staff in charge: -
  • Location: Barcelona Esplugas

Education

  • Bachelor’s degree in Medicine or Pharmacy, or other health sciences.
  • Master’s degree in Regulatory Affairs or in Pharmaceutical Industry.
  • Excellent level of scientific and business English, spoken and written.
  • Excellent computer skills

Previous experience required

  • Minimum 1-2 years experience in the area of registration of medicines for human use, preferably generic drugs. Very valuable to have experience and knowledge in non-EU regulated markets requirements, as for example, LATAM and ASEAN.

Roles and Responsibilities

  • Compilation, evaluation and submission of complete registration dossiers to local and international regulatory agencies, of Galenicum developed products and licensing in from other companies.
  • Monitoring, updating and adapting documents, preparing submissions of license variations and renewals.
  • Support in developing and writing clear arguments and rationale according to Health Authorities’ requests.
  • Proactively taking part in internal regulatory strategies.
  • Auditing 3ºpart registration dossiers and DMFs.
  • Conducting Regulatory Affairs related trainings courses.
  • Maintenance of approved dossiers and RA internal databases.
  • Providing advice about corresponding regulations to other departments of the company.
  • Ensuring compliance with regulations set by corresponding Health Authorities, as applicable.
  • Keeping up to date with changes in applicable regulatory legislation and guidelines.
  • Liaising and negotiating with applicable regulatory authorities.

Skills

  • Highly disciplined, responsible, methodical, resolutive and organized individual.
  • Excellent oral and written communication and interpersonal skills.
  • Strong attention to detail and analytical frame of mind.
  • Understanding of both legal and scientific matters.
  • Capable to work under pressure and to strict deadlines, under your own initiative whilst being a good team player.
  • GMPs knowledge is also a plus.

Apply now

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Thanks for your interest in Galenicum. We will get back to you if your profile is a match.

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