Director of Regulatory Affairs

2 months ago

Oxford, Oxfordshire, United Kingdom Cpl Full time

Job Title: Director of Regulatory Affairs (CMC)

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 CMC knowledge to an early-stage development programs, with a global focus.

In this role as a Director of Regulatory Affairs CMC you will provide strategic regulatory input for assigned assets and to lead regulatory activities. You will manage worldwide interactions and negotiations with regulatory agencies and partners in support of radiopharmaceutical development activities. You will take the lead on Regulatory CMC related activities and work as a subject matter expert for assigned assets. 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.

Role Responsibilities:

· Act as primary contact with external regulatory bodies, as required, to ensure appropriate input into regulatory strategy, gain rapid approval of submissions and resolve any regulatory issues.

· Confident with submissions into the US, LATAM, APAC and EU regions with swift approvals.

· Planning, preparation and internal review of CMC documentation for Clinical Trial Applications, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities.

· Attend project team meetings and provide CMC-related regulatory guidance to other functional areas, including, but not limited to Manufacturing, Quality, and Commercial Operations.

· Advise on global CTA submission strategy and provide regulatory guidance to company personnel throughout the research and development process.

· Direct life cycle management for assigned assets on a global basis, including regulatory impact assessments and preparation of CMC documentation for variations and other post-marketing submissions.

· Develop and maintain the Core Data Sheet and lead labelling team meetings for projects within area of responsibility.

· For projects/products within area of responsibility, directs regulatory strategies which meet businesses goals and ensures execution of critical deliverables in line with global regulatory strategy and planning, working in partnership to support inputs into product development plans.

· Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.

· Mentor and guide direct reports in carrying out responsibilities. Responsible for coordinating activities and career development of direct reports.

Job Requirements:

· Degree in Life Science or related discipline required. Higher degree preferred (PharmD, MSc, PhD, MBA).

· At least 12 years of experience dedicated to Regulatory Affairs with a focus on early stage development.

· Pharmaceutical/biotechnology industry experience with technical management experience. Regulatory Affairs experience with a focus on CMC documentation and CMC lifecycle management within the pharmaceutical or biotechnology industry is required.

· Working knowledge of FDA and EMA CMC guidance documents and regulations as well as working knowledge of international (e.g., LATAM and APAC) CMC requirements for investigational and marketed products is required.

· Ability to lead and influence project teams, committees, etc. to attain group goals

· Supervisory/mentoring experience, including ability to guide, train, supervise and prioritize workload of direct reports.

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

Please note you MUST hold he FULL RIGHT TO WORK IN

THE UK as this employee cannot offer sponsorship.

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