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Biomapas

Local Regulatory Affairs Manager in Spain (Freelance/Part-time)

part-time Remote

AI overview

Drive regulatory strategy and compliance for medicinal products while collaborating closely with the Regulatory Affairs team and local authorities.

Freelance opportunity in Spain! Join our global team as a Local Regulatory Affairs Manager in Spain.

Local Regulatory Affairs Manager will be responsible for ensuring that medicinal and other products comply with applicable regulatory requirements by providing input and coordinating marketing authorization and post-authorization related activities.

The position is remote (approximately 0.25 FTE) and covers Spain, working in close collaboration with the Regulatory Affairs team.

You have energy and motivation to work in a team and to gain more experience?

Submit your CV in the English language for consideration.

 

Responsibilities:

  • Act as Local Regulatory Affairs Manager in the assigned territory.
  • Maintain timely and effective communication with local Competent Authorities.
  • Monitor and report changes in national regulatory requirements on a regular basis.
  • Develop and/or review of regulatory strategy to support product lifecycle planning, including initial market entry and post-approval changes.
  • Prepare regulatory documentation for submission to Competent Authorities. Regulatory submissions.
  • Regulatory review for labelling components (e.g., packaging, patient leaflets, SmPC), promotional materials, and product information to ensure full compliance with applicable regulatory requirements.
  • Translations.
  • Ensure accurate documentation, reporting, and follow-up of all regulatory reports.
  • Support Biomapas Clients with other RA-related tasks, including strategic and operational regulatory advice.

Requirements

  • Biologist, Pharmacist, Medical Doctor, or other life science degree
  • Fluent written and spoken English and Spanish
  • At least 2 years of experience in local regulatory affairs activities
  • Experience with local documents preparation and regulatory submissions
  • Excellent knowledge of local and international regulations (including knowledge concerning orphan medicinal products and the market entry aspects of centrally authorized medicines)
  • High motivation to develop and learn within the team
Biomapas

Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success.

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