TR- Market Access and Regulatory Affairs Lead

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

This person will lead processes for pricing, reimbursement ,access, stakeholder engagement, regulatory affairs and Daiichi Sankyo Turkey cardiovascular and oncology portfolio. She will be working closely with affiliate commercial teams and with regional teams, DSTR brand teams including Pricing, Reimbursement and Access , Regulatory Affairs, Marketing and Medical Affairs. This person will support the market Access, regulatory affairs team in Turkey will be reporting to Market Access and Regulatory Affairs Director and will be working in close collaboration with DS International Regulatory Affairs DSE Oncology & Specialty Medicine & DSE Market Access OBU & SBU.

Job Description

• Lead development of pricing, reimbursement,HTA and access activities working cross-functionally/regionally
• Enhance information exchange and best practice sharing across MSC and DSE; drive adoption of pricing tools and resources
• Ensure price submissions are done accurately and timely manner while working closely with DSE price team for IRP process, tracking reimbursement and pricing lists, stakeholder engagement
• Generation of reimbursement dossier in line with local requirements while generating local data and adapting Global CE models
• Insight generation and information among DSTR teams regarding competitors and DSTR porftolio pricing, reimbursement and sectoral analysis & closely monitoring developments in healthcare environment
• Stakeholder engagement for OBU & SBU (KOLs, SSI)
• Determining price strategies of the products which are licenced or to be licenced and price application to Ministry of Health
• Lead all SmPC and PL proceses (Labelling activities)
• Collaborate for the generation of prioritization submissions for GMP and MAA & GMP inspection submissions
• Preparation registration file in eCTD format
• Life-cycle management of established products (Variation submissions)
• Follow-up the registration steps on the process
• Registration renewal submission

Skills and additional Requirements

• Bachelor degree on pharmacy and life sciences
• 2 or more years of hands on experience acquired at pharmaceutical companies,
• Demonstrated experience with developing pricing, reimbursement and access & RA strategies
• Strategic mindset, analytical and hands-on experience
• The ability to work well in a matrix team environment and independently
• Excellent communication skills (oral and written)
• Strong process/project management skills
• Strong business acumen & solution-oriented
• Fluency in English
• Agile mindset and willing to work in a dynamic environment

Why work with us?

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