Regulatory Affairs Specialist

4 settimane fa

Pisa, Italia Regulatory Pharma Net A tempo pieno

**Tasks and Responsibilities**:
Prepares the strategy, the technical documentation, performs 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.
Gives support for the electronic submission (eCTD) and preparation of checklists and e-submission ready documents for different regulatory activities.
Gives support for the fulfilment of post approval requirements at local level (databases update, PI update, artworks revision, contacts with partners on behalf of MAHs).
Gives pre
- and post-marketing regulatory consultancies concerning adherence to Italian regulations.
Performs the daily review of communications/regulations circulated by the Italian Authorities / EMA.
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.
Gives support to the Client in the critical evaluation of the appropriate regulatory strategy.
**Essential Requirements**:
Degree in Pharmaceutical Chemistry and Technology, Pharmacy or similar.
Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
At least 3 years of experience in similar roles.
**Soft Skills**:
Communication and teamwork.
Attention to detail and organizational skills.
Time management and problem-solving.
Adaptability and resilience.

  • Regulatory Affairs Manager

    2 giorni fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    About UsWe support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions, according to the needs of national markets in the European Union, the United States and more.We are looking for an experienced and results-driven REGULATORY AFFAIRS MANAGER with expertise in the...

  • Regulatory Affairs Professional

    2 giorni fa

    Pisa, Toscana, Italia Regulatory Pharma Net - RPN A tempo pieno

    About UsWe support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions, according to the needs of national markets in the European Union, the United States and more.Job DescriptionAs a seasoned Regulatory Affairs Manager, you will be responsible for leading...

  • Regulatory affairs manager

    22 ore fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    About Us We support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions , according to the needs of national markets in the European Union, the United States and more. We are looking for an experienced and results-driven REGULATORY AFFAIRS MANAGER...

  • Regulatory Affairs Manager

    2 giorni fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    About Us We support pharmaceuticalandlife science companiesthroughout the wholeproduct life cyclewith tailoredRegulatory AffairsandMarket Access solutions, according to the needs of national markets in the European Union, the United States and more.We are looking for an experienced and results-drivenREGULATORY AFFAIRS MANAGERwith expertise in the management...

  • Regulatory Affairs Manager

    1 giorno fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    About UsWe support pharmaceuticalandlife science companiesthroughout the wholeproduct life cyclewith tailoredRegulatory AffairsandMarket Access solutions, according to the needs of national markets in the European Union, the United States and more.We are looking for an experienced and results-drivenREGULATORY AFFAIRS MANAGERwith expertise in the management...

  • Regulatory Affairs Intern

    6 giorni fa

    Pisa, Italia Regulatory Pharma Net - Rpn A tempo pieno

    About UsWe support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions , according to the needs of national markets in the European Union, the United States and more.We are looking for a young professional to join our Regulatory Affairs team.What do we offer?A dynamic...

  • Regulatory Affairs Intern

    6 giorni fa

    Pisa, Italia Regulatory Pharma Net - Rpn A tempo pieno

    About UsWe support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions, according to the needs of national markets in the European Union, the United States and more.We are looking for a young professional to join our Regulatory Affairs team.What do we offer?A dynamic...

  • Regulatory Affairs Intern

    1 settimana fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    About UsWe support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions, according to the needs of national markets in the European Union, the United States and more.We are looking for a young professional to join our Regulatory Affairs team. What do we offer?A dynamic...

  • Regulatory Affairs Intern

    6 giorni fa

    Pisa, Italia Regulatory Pharma Net - Rpn A tempo pieno

    About Us We support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions , according to the needs of national markets in the European Union, the United States and more.We are looking for a young professional to join our Regulatory Affairs team.What do we offer?A dynamic...

  • Regulatory Affairs Intern

    6 giorni fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    About UsWe support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions , according to the needs of national markets in the European Union, the United States and more. We are looking for a young professional to join our Regulatory Affairs team....

  • Regulatory Affairs Intern

    7 giorni fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    About Us We support pharmaceuticalandlife science companiesthroughout the wholeproduct life cyclewith tailoredRegulatory AffairsandMarket Access solutions, according to the needs of national markets in the European Union, the United States and more.We are looking for a young professional to join ourRegulatory Affairsteam.What do we offer? A dynamic and...

  • Regulatory Affairs Intern

    7 giorni fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    About UsWe support pharmaceuticalandlife science companiesthroughout the wholeproduct life cyclewith tailoredRegulatory AffairsandMarket Access solutions, according to the needs of national markets in the European Union, the United States and more.We are looking for a young professional to join ourRegulatory Affairsteam.What do we offer?A dynamic and...

  • Regulatory Affairs Manager

    2 giorni fa

    Pisa (PI), Italia Regulatory Pharma Net - RPN A tempo pieno

    About Us We support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions , according to the needs of national markets in the European Union, the United States and more. We are looking for an experienced and results-driven REGULATORY AFFAIRS...

  • Regulatory Affairs Manager

    2 giorni fa

    Pisa (PI), Italia Regulatory Pharma Net - RPN A tempo pieno

    About Us We support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions , according to the needs of national markets in the European Union, the United States and more. We are looking for an experienced and results-driven REGULATORY AFFAIRS MANAGER with...

  • Regulatory Affairs Manager

    2 giorni fa

    Pisa (PI), Italia Regulatory Pharma Net - RPN A tempo pieno

    About Us We support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions , according to the needs of national markets in the European Union, the United States and more. We are looking for an experienced and results-driven REGULATORY AFFAIRS MANAGER with...

  • Regulatory Affairs Manager

    2 giorni fa

    Pisa (PI), Italia Regulatory Pharma Net - RPN A tempo pieno

    About Us We support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions , according to the needs of national markets in the European Union, the United States and more. We are looking for an experienced and results-driven REGULATORY AFFAIRS MANAGER with...

  • Regulatory Affairs Intern

    2 settimane fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    About Us We support pharmaceutical and life science companies throughout the whole product life cycle with tailored Regulatory Affairs and Market Access solutions , according to the needs of national markets in the European Union, the United States and more. We are looking for a young professional to join our Regulatory Affairs team. What do we...

  • Regulatory Affairs International

    3 settimane fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    We provide pharmaceutical and life science companies with the strategic, in-market, and executional expertise needed to deliver successful Regulatory Affairs and Market Access outcomes throughout the entire product life cycle and across international markets.We are looking for a REGULATORY AFFAIRS to join our INTERNATIONAL TEAM.You will play a key part in...

  • Regulatory Affairs International

    3 settimane fa

    Pisa, Italia Regulatory Pharma Net - Rpn A tempo pieno

    We provide pharmaceutical and life science companies with the strategic, in-market, and executional expertise needed to deliver successful Regulatory Affairs and Market Access outcomes throughout the entire product life cycle and across international markets.We are looking for a REGULATORY AFFAIRS to join our INTERNATIONAL TEAM.You will play a key part in...

  • Regulatory Affairs International

    2 settimane fa

    Pisa, Italia Regulatory Pharma Net - RPN A tempo pieno

    We provide pharmaceutical and life science companies with the strategic, in-market, and executional expertise needed to deliver successful Regulatory Affairs and Market Access outcomes throughout the entire product life cycle and across international markets. We are looking for a REGULATORY AFFAIRS to join our INTERNATIONAL TEAM. You will play a key...