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REGULATORY PHARMA NET

REGULATORY PHARMA NET

RPN – Life Science Solutions

RPN supports 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.

Mission
We believe that building and maintaining a team of exceptional talent is essential to our continued success.

Our Core Values
♦︎ Dedication & Commitment: We are deeply dedicated to our work, our customers, and our team. We expect our employees to show the same level of commitment and passion in everything they do.
♦︎ Integrity: We believe in doing the right thing, even when no one is watching. Honesty and transparency are key components of our company culture.
♦︎ Dynamism: We thrive in a fast-paced environment and embrace change. Our employees are adaptable, energetic, and always ready to tackle new challenges.
♦︎ Collaboration: Teamwork is at the heart of our success. We encourage open communication, mutual respect, and the sharing of ideas to achieve common goals.
♦︎ Incisive Thinking: We value sharp, analytical minds that can think critically and solve problems effectively. Our employees are encouraged to think deeply and make informed decisions.
♦︎ Excellence: We strive for the highest standards in everything we do. Our commitment to excellence drives us to continually improve and deliver outstanding results.

Our Services
Our services across the entire product lifecycle include:
♦︎ Drug Development
♦︎ Regulatory Affairs
♦︎ Market Access
♦︎ Pharmacovigilance
♦︎ Quality & Compliance

Company
Title

Regulatory Affairs Specialist – Procedures
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Place of work: Pisa (onsite position)

Type of contract: internship – possibility of permanent employment at the end of the internship period (hybrid work)

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.

 

 

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Value & Access Specialist – Health Economics
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Place of work: Pisa (onsite position)

Type of contract: internship – possibility of permanent employment at the end of the internship period (hybrid work)

What will you deal with?

  • Supports development of P&MA assessments: overview of Italian landscape and competitors in the specific therapeutic area, identification of potential issues and hurdles.
  • Supports the adaptation of economic models: Budget Impact Model (BIM) and cost-effectiveness model (CEM) and writing of the Economic Section of the AIFA P&R Dossier.
  • Supports preparation of Pricing and Reimbursement (P&R) dossiers according to the Italian AIFA requirements (any kind of dossier, from medicinal specialties to generics, from new applications to renegotiation applications, etc.), and submission to the Italian Agency.
  • Supports logistics of advisory boards with KOLs and/or payer experts (recruitment, contracting, reporting) and Face2Face/telephone interviews (recruitment, contracting, interview, reporting).

What are the requirements?

  • Master's degree in Pharmaceutical Chemistry and Technology or Economics, with specialization in Health Economics.
  • 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.

 

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Regulatory Affairs – Promo & Congresses (Internship)
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Place of work: Pisa (onsite position)

Type of contract: internship – possibility of permanent employment at the end of the internship period (hybrid work)

What will you deal with?

  • Manage promotional materials: ensure that all promotional contents and initiatives for pharmaceutical products complies with regulatory requirements and industry standards, overseeing the approval process before materials are used in marketing campaigns.
  • Collaborate with cross-functional teams: work closely with marketing, medical, and legal teams to align promotional strategies with regulatory guidelines, ensuring that messaging is accurate, compliant, up-to date and sufficiently complete.
  • Liaise with regulatory authorities: be responsible for submitting promotional materials to regulatory bodies for review, addressing any feedback or required modifications to ensure timely approval and market readiness.

What are the requirements?

  • Master's degree in Pharmaceutical Chemistry and TechnologyPharmacy or similar.
  • 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. 
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