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Regulatory Affairs Specialist – Procedures

Place of work: Pisa (hybrid work)

Type of contract: permanent employment

What will you deal with?

  • Prepare the strategy, the technical documentation, perform the submission (through national and EU portals) and follow-up until approval of MRP, DCP, CP and National Procedures for new marketing authorizations, variations, marketing authorization transfers and renewals according to the relevant EU Regulation and national requirements.
  • Give support for the electronic submission (eCTD) and preparation of checklists and e-submission ready documents for different regulatory activities.
  • Manages the regulatory procedures in coordination with the Client’s team and the contact with Regulatory Authorities together with or on behalf of the client.

What are the requirements?

  • Degree in Pharmaceutical Chemistry and TechnologyPharmacy or similar.
  • At least 1 year of experience in similar roles.
  • Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
  • Ability to work in a team and aptitude for learning.

What we offer?

  • Dynamic and challenging work environment with international projects.
  • Ongoing training and opportunities for professional growth.

 

Degrees of interest: Laurea in Farmacia o CTF e affini

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