Job Title: Director of Regulatory Affairs
Start-up biopharmaceutical company focused on the development and commercialisation of engineered T-cell immunotherapy products, with extreme efficacy in the treatment of life-threatening cancers. Based in London.
Significant experience in Regulatory Affairs including submissions with ATMPs (Advanced Therapy Medicinal Product). Working knowledge of ATMP legislation. Experience with drug development and clinical trial applications in the EU. Experience with INDs would be advantageous. Experience in interfacing with the EMA and national authorities in Europe and an excellent track record of building relationships with and influencing outcomes.
The company is currently using external regulatory advisors, and the successful applicant will be the first member of the Company’s Regulatory Affairs group. They will provide strategic regulatory leadership to project teams in early and late stage clinical development, and for ensuring the development and implementation of appropriate risk-based regulatory strategy and policies.
PiR is a specialist recruitment company, established for over a decade, focused exclusively on identifying senior talent who deliver strategically and operationally to international life sciences organisations.
The relevance and depth of PiR’s expertise is reflected in the team’s combined life science recruitment experience of over 40 years; across key business functions at leadership and expert level. Our exclusive focus on, and network in, the sector ensures our solutions are aligned and relevant to client companies, reflecting our inherent understanding of the life science industry.
PiR’s client services include:
• Executive Search
• Interim Management Services
• Talent Mapping
PiR’s team is aligned to provide a depth of expertise across key business segments:
• Early stage, investor backed and SME organisations, as well as mid-capped specialist companies. These include advanced and novel therapies (cell, gene, and RNAbased), orphan drugs and innovative medical technology
• Building senior teams for newly funded and growing organisations
• Director, leadership and expert level; Medical/Medical Affairs, Clinical, Regulatory, Manufacturing Operations (including Quality and Supply Chain) and Commercial (HEOR, Pricing & Reimbursement, Market Access, product management)
• Board level appointments (CEO, CBO, COO, CSO, CMO, Chair, NED)
To learn more about PiR, please contact Sally Hope, CEO at email@example.com. Tel: + 44 (0) 1480 499580