Senior Director, Regulatory Affairs

Job Title: Senior Director, Regulatory Affairs

Location: Oxfordshire, United Kingdom

Salary: Attractive salary plus benefits package (stock options, car allowance, bonus)

Job Type: Full time, permanent position

Working for one of the industry’s most innovative clinical stage biotechnology companies, this is a fantastic opportunity to provide expert regulatory knowledge to an early-stage development programs, with global focus. 

In this role as a Senior Director, Regulatory Affairs you will manage worldwide interactions and negotiations with regulatory agencies and partners in support of radiopharmaceutical development activities. It is essential you have experience with FDA and therapeutic oncology trials. You will be a key member of project teams and responsible for developing regulatory strategy across the company. You will be responsible for ensuring the regulatory strategy is aligned with health authority requirements and regulatory submissions are on time and of high quality.

Job responsibilities:

·       Working as a SME for the global regions responsible for all interactions with health authorities including driving global strategies for developing assets.

·       Leading program teams in preparing regulatory submissions including briefing documents, IND and CTA filings.

·       Execute clinical trial applications for assigned programs and provide leadership for team members responsible.

·       Responsible for all areas of drug development including initial CTAs global, IND, NDA, BLAs, PIPS, ODD, IMPD, and Initial MAAs.

·       Overseeing preparation of responses to all regulatory authority queries.

·       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.

·       Serving as the primary regulatory representative at internal meetings as well as at meetings with regulatory agencies for all clinical related issues

·       Developing and maintaining detailed knowledge of global regulatory environment relevant for oncology therapeutics including accelerated review programs, and communicating changing regulatory agency requirements.

·       Collaborating with external consultants, clinicians, CROs to provide regulatory guidance

·       Evaluating regulatory program risks and establish mitigation strategies to optimise clinical development.

·       Partnering with CMC, Non-Clinical, and Clinical Development organizations to innovate strategies to accelerate submission timeline

·       Escalating issues to Senior Management that affect regulatory compliance.

·       Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals with competitively differentiated labelling.

Job requirements:

·       Advanced degree in a scientific discipline.

·       A minimum of 15 years of regulatory experience with a focus on Radiopharmaceuticals supporting products through clinical development.

·       Ideally a background in Oncology or extensive experience working in this therapeutic area.

·       Experience of managing and developing staff members desirable.

·       Proven track record of supporting Global Clinical Trial Applications through approval and study start up.

·       Knowledge of both EMA and FDA regulations is required. Experience in filing regulatory submissions required.

·       Experience directly writing submission documents is preferred

·       Strong coaching, facilitation, and organizational skills, team player.

·       Ability to negotiate and concisely express clear positions to stakeholders at all levels.

·       Experience of directly working with national regulatory agencies and leading agency meetings face to face.

This is a great opportunity for a science-minded individual to work at the heart of innovation on a developing Radiopharmaceuticals and Oncology portfolio. You will take the lead and work with senior board members across the globe to define regulatory / business strategy.

If you are interested in this role or would like more details please email your CV to [email protected]

Please note you MUST hold he FULL RIGHT TO WORK IN THE UK as this employee cannot offer sponsorship.