Job title: Senior Director, Regulatory Affairs – Phase 1 Oncology Biotech
An Oxfordshire based clinical stage biotech company focused within Oncology are seeking a senior director of regulatory affairs. This is their first hire within regulatory affairs and you will play a pivotal role in building a regulatory affairs function. You will manage worldwide interactions and negotiations with regulatory agencies and partners in support of regulatory development activities. It is essential you have extensive experience with the FDA and therapeutic oncology trials.
The business has an exciting product portfolio initially focused on prostate cancer with plans to expand into additional disease areas in oncology.
Responsibilities:
- Leading program teams in preparing regulatory submissions including briefing documents, IND and CTA filings
- Planning and leading meetings with regulatory authorities
- Managing critical clinical regulatory timelines, working with team members to resolve issues related to clinical development and ongoing clinical trials, and working in partnership with the CMC team.
- Collaborating with external consultants, clinicians, CROs to provide regulatory guidance
- Developing and maintaining detailed knowledge of global regulatory environment relevant for oncology therapeutics including accelerated review programs, and communicating changing regulatory agency requirements
Requirements:
- A minimum of an undergraduate degree in biological, pharmaceutical, chemical or engineering sciences is required with postgraduate education and/or an advanced scientific degree preferred in the sciences, or health related field
- Knowledge of both EMA and FDA regulations is required. Experience in filing regulatory submissions required.
- Experience of leading regulatory strategy for the clinical development of therapeutic oncology products
- Extensive Oncology experience is required. Experience of prostate cancer products is advantageous
Salary and benefits:
A highly competitive salary, annual bonus and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
