Market Access and Regulatory Advisor

Há 7 dias


Lisboa, Portugal MCR International Tempo inteiro

JLF-2307-152

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



  • Lisboa, Portugal Pharmalex Tempo inteiro

    **We are growing, grow with us!** Are you looking for a dynamic company with daily new challenges and opportunities? Then, Cencora Pharmalex is your career opportunity. Cencora Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market...


  • Lisboa, Portugal Pfizer Tempo inteiro

    1. ROLE PURPOSE The Market Access Manager supports all activities and deliverables to obtain and maintain Market Access, Reimbursement and optimal Pricing for Pfizer’s products. He/She works with the cross-functional team to develop access strategies that are in line with the overall brand strategy and helps implement key activities targeted at external...


  • Lisboa, Portugal GSK Tempo inteiro

    **Site Name**: Lisbon **Posted Date**: Apr 8 2025 **Job Purpose**: We are recruiting a Market Access Manager reporting to the Market Access Lead. **Main Responsibilities** - Developing and implementing the market access strategy for new and existing medicines within cross-functional brand teams - Leading reimbursement processes with national authorities -...

  • Pricing, Tenders

    2 semanas atrás


    Lisboa, Portugal Organon Tempo inteiro

    **The Position** In Portugal, the **Pricing, Tenders & Market Access (PTMA) Senior Specialist** plays a crucial role in ensuring we define optimized strategies to our current and future portfolio in straight collaboration with key internal and external stakeholders to meet strategic business goals. The PTMA Senior Specialist is responsible to map market...

  • Market Access Trainee

    2 semanas atrás


    Lisboa, Portugal Organon Tempo inteiro

    **Job Description**: Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon...

  • Legal Advisor

    Há 7 horas


    Lisboa, Portugal JUJUR Tempo inteiro

    Position: Legal Advisor Location: Lisbon, Portugal Work model: on-site Employment type: fixed term (6 months) **DUTIES AND RESPONSIBILITIES**: - Serve as a liaison between the organization and external legal representatives, regulatory agencies, and enforcement bodies. - Manage and respond to inquiries from national regulatory authorities responsible...


  • Lisboa, Portugal Biogen Tempo inteiro

    **About This Role** The Marketing & Market Access Trainee is responsible for understanding and learning about Marketing programs targeted towards physicians, nurses, and other healthcare professionals, as well as supporting the development of Value & Access (V&A) programs aimed at hospital pharmacists. Furthermore, he/she will enhance self-skills by...

  • Access & Value Trainee

    2 semanas atrás


    Lisboa, Portugal MSD Tempo inteiro

    We are looking for an **Access & Value Trainee** to join our team, who will focus patient access to innovative therapies. He/she will have the opportunity to join a multinational company and develop knowledge in market access, pricing, health economics and outcomes research. Operationally, will support the development of reimbursement dossiers and...

  • Trading Analytics

    4 semanas atrás


    Lisboa, Portugal Devs.pt Tempo inteiro

    A prominent consultancy in Lisbon is looking for a skilled Business Analyst to enhance their team. Ideal candidates should have 6 to 9 years of experience in electronic trading or market access, along with a strong understanding of financial products. This role offers excellent career progression along with benefits like health insurance and personalized...


  • Lisboa, Portugal Syneos - Clinical and Corporate - Prod Tempo inteiro

    **Description** Regulatory CMC Manager/Regulatory Consulting - hybrid/remote (Serbia, UK, Portugal) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical...