Market Access and Regulatory Advisor

1 semana atrás

Lisboa, Lisboa, Portugal MCR International Tempo inteiro

JLF

MARKET ACCESS AND REGULATORY ADVISOR

LISBON

Purpose of the position:

  • Responsible for developing, communicating and executing market access strategy with local/regional Business Groups and with Global Regulatory Partners, aligned with the company's global regulatory strategy.
  • Prepare all the submission prices dossiers and pharmacoeconomic justification for negotiation with Portuguese payors and authorities.
  • Collaboration in the local price negotiations with Portuguese payors and authorities.
  • Operate as the Portugal Local Safety Officer maintaining oversight of Pharmacovigilance activities in Portugal.
  • Maintain current knowledge of regulations, legislations, guidelines and requirements in the field of Regulatory, Pharmacovigilance and Quality Assurance. Communicate relevant changes to global/local functions concerned in order to ensure compliance and that the most appropriate strategy is taken.

Responsibilities:

Market Access:

  • Develop the payer and market access strategy with continuous mapping of affiliate needs to adapt HTA documents and core value story for pricing and reimbursement on a Federal and Regional level.
  • In conjunction with the Medical Director and the BU Head develop a pricing strategy and conduct negotiations leading to rapid access
Regulatory Affairs

  • Develop strategies for local submissions to maximise commercial competitiveness of company products in Portugal. Represent our client in its dealings with the Ministry of Health. Act as the official contact with local Regulatory Authorities
  • To liaise with Global Regulatory colleagues to advise market specific requirements, provide strategic local insight and drive the development of submission strategies for New Products, Line Extension and Variation submissions.
  • Preparation of Submission Labelling (PIL, Product Information) and Artworks.

Pharmacovigilance:

  • Local Safety Officer once our client's affiliate.
  • Collection and reporting of adverse events related to our client medicines.

Quality:

  • Support the local and global teams for Quality related matters and compliance to MA, providing support to respond to technical product questions, assuring procedures related to the supply and distribution of medicinal products in accordance with Good Manufacturing and Good Distribution Practices are followed.
  • Develop and maintain a local Quality Management System in accordance with local regulations to include as a minimum (additional elements in accordance with local requirements will also be required): Complaints, Returns, Recalls.
  • Collaborate with EMEA Quality Operations for all Quality compliance related matters.
Detalles / Details

Ciudad / City
Lisbon

  • País / Country

PORTUGAL

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