Market Access and Regulatory Advisor
3 meses atrás
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
-
Pricing, Tenders
1 semana atrás
Lisboa, Portugal Biom?Rieux Bv Tempo inteiro.Job DescriptionThe PositionIn 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...
-
Pricing, Tenders
2 semanas atrás
Lisboa, Portugal Organon Tempo inteiro.The PositionIn 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 access...
-
Market Access Specialist
4 meses atrás
Lisboa, Portugal Johnson & Johnson Tempo inteiroJohnson & Johnson is recruiting for a **Market Access Specialist **located in **Lagoas Park, Lisbon, Portugal.** **Duties and Responsibilities**: - Contribute, design, develop and implement a coordinated approach to all aspects of the payer value proposition from early development through and beyond loss of exclusivity. - Elaborate the local access...
-
Senior Associate, Market Access and Value
4 meses atrás
Lisboa, Portugal Fortrea Tempo inteiroAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Energy Access Grant Advisor
3 meses atrás
Lisboa, Portugal Enzen Portugal Tempo inteiroEnzen Global was founded in 2006. It’s a company that acts exclusively in the energy sectors, more specifically in electricity, gas, and water, present in 7 countries such as Australia, India, Portugal, Spain, Turkey, the UK and the US. In 2021 Enzen Portugal opened as a branch of Enzen Global. It operates mainly in the Iberian market with a special focus...
-
Pricing, Tenders
1 semana atrás
Lisboa, Portugal Biom?Rieux Bv Tempo inteiro.Job Description 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...
-
Pricing, Tenders
1 semana 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 access...
-
Specialist Market Access
4 meses atrás
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...
-
Market Access Manager
3 meses atrás
Lisboa, Portugal Johnson & Johnson Tempo inteiroJohnson & Johnson is recruiting for a **Market Access Manager **located in **Lagoas Park, Lisbon, Portugal.** Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people....
-
Pricing, Tenders
1 semana atrás
Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob DescriptionThe 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 Access Specialist
4 meses atrás
Lisboa, Portugal Johnson & Johnson Tempo inteiroJanssen is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. Who is Janssen? We’re people: more than 35,000, working hard to treat, cure, stop and prevent some of the most devastating and complex diseases of our time. We are driven to action by the plight of patients, and we aspire to make a positive...
-
Pricing, Tenders
2 semanas atrás
Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob DescriptionThe PositionIn 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...
-
Pricing, Tenders
2 semanas atrás
Lisboa, Portugal Organon Tempo inteiroThe PositionIn 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 access...
-
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...
-
Pricing, Tenders
2 semanas atrás
Lisboa, Portugal Organon Tempo inteiroJob DescriptionThe PositionIn 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, Policy
4 meses atrás
Lisboa, Portugal Organon Tempo inteiro**Job Description**: Therefore, we are currently looking for a: **Market Access, Policy & Communications Lead (Associate Director Level)** This role is based in Lisbon. **Purpose of the role** As Market Access, Policy & Communications Lead you will be part of Organon's Leadership Team in the Portuguese subsidiary. Working closely with the Managing...
-
Pricing, Tenders
2 semanas atrás
Lisboa, Portugal Organon Tempo inteiroJob DescriptionThe PositionIn 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
4 meses atrás
Lisboa, Portugal Boehringer Ingelheim Portugal, Lda Tempo inteiro**THE OPPORTUNITY**: Are you ready to be developed in one of the leading pharmaceutical companies in the world? Are you curious to know how pharmaceutical world really looks like? Then start your next adventure by joining our multicultural and fun team in Portugal! We are looking for a talented and motivated **Market Access Intern **. During your internship...
-
Regulatory Liaison Counsel
4 semanas atrás
Lisboa, Portugal Sovos Compliance Tempo inteiro**Build your future with Sovos.** If you're seeking a career where innovation meets impact, you've come to the right place. As a global leader, Sovos is transforming tax compliance from a business requirement to a force for growth while revolutionising how businesses navigate the ever-changing regulatory landscape. At Sovos, we're dedicated to more than...
-
Market Access
Há 1 mês
Lisboa, Portugal Bayer Tempo inteiroMarket Access & Public Affairs Specialist At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding...