Mission:
You will support the design and implementation of a strategic market access roadmap in compliance with health and safety rules and regulations, including budgets and deadlines. In interaction with our R&D and corporate management teams as well as our CMO, your work will contribute to strategic decisions for the company.
In particular, your primary responsibilities will be to:
- Regulatory Strategy Development: Develop and implement regulatory strategies aligned with business objectives to facilitate timely approvals for drug development and commercialization. It includes the redaction of a Target Product Profile and its update.
- Market Access Planning: Lead market access assessments and develop strategies to optimize future reimbursement, pricing, and access to the drug candidate in the US and European markets.
- Regulatory Submissions: Participate in the preparation, submission, and maintenance of regulatory filings, including INDs, CTA, ODD, …, ensuring accuracy and completeness of documentation.
- Participate in the management of outsourced studies with CROs or academic partners.
You will also be involved in:
- Cross-functional Collaboration: Collaborate closely with cross-functional teams, including R&D, clinical development and corporate management teams, to integrate regulatory and market access as well as quality assurance and legal considerations into product development.
- Regulatory Intelligence: Stay abreast of evolving regulatory and market access requirements, guidelines, and trends in the pharmaceutical industry, providing insights and recommendations to internal stakeholders.
- Risk Management: Identify regulatory and market access risks and develop mitigation strategies to address potential challenges or obstacles to product approval and market access.
Experience:
- 1 to 3 years’ experience in the market access and regulatory field in a biotech or pharmaceutical company or in a consulting firm.
- A previous experience in oncology therapeutic area will be a plus.
Education:
- MSc degree in Pharmacy or Biology.
- Post degree qualification in Regulatory Affairs, Health Economics and Market Access or Healthcare Management.
Skills:
- In-depth knowledge of regulatory requirements and processes in the US (FDA) and Europe (EMA), with experience navigating regulatory submissions and interactions.
- Understanding of the global healthcare, policy, market access principles, pricing and reimbursement mechanisms in the US and Europe.
- Fluent speaking and writing in English.
- Ability to work with multidisciplinary teams.
- Rigour with analytical spirit, organization, autonomy, proactivity.
- Thorough interest in a young biotech company work environment, taste for innovation.
Duration
Fixed-term contract, 6-months contract, starting as soon as possible
Salary and benefits
Fixed salary commensurate with experience
+ performance bonus based on achievements of objectives
+ luncheon vouchers.
Application
Send CV and cover letter to application@pep-therapy.com.
Please clearly indicate “Market Access” in the subject line, and your possible start date in your email.
About us:
PEP-Therapy is a clinical-stage biotechnology company developing first-in-class peptides as targeted therapies in oncology. PEP-010, our lead product, is in Phase Ia/b clinical trials for the treatment of advanced solid tumors and in particular platinum-resistant ovarian cancer and pancreatic ductal adenocarcinoma.
PEP-Therapy was founded in 2014 and builds on research results from Institut Curie and Sorbonne University. The company is backed by international investors.
For further information: www.pep-therapy.com