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 Technology, Pharmacy 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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