Head of Regulatory

The Head of Regulatory Affairs will be the first Regulatory person in my clients organisation whose key purpose is to set the strategy and then build out the team. This person shall work closely with and assist in providing regulatory intelligence support, strategic regulatory advice, compiling regulatory submission packages and executing submissions to regulatory agencies in EU, USA and worldwide (where required) in a timely fashion to support all applications.

The position will collaborate with internal cross functional teams to provide regulatory input into clinical programs with CROs to ensure appropriate oversight and the timely submission, approval, and compliance of CTA/IND applications. This position will also require key contributions to department and company initiatives related to regulatory affairs operations and strategy.

Essential Functions

1. Provide regulatory leadership on project teams and working collaboratively with the project teams to identify optimum regulatory strategies for assigned projects.
2. Build and lead teams in examining regulatory strategy options and relevant regulatory guidance and precedent.
3. Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks.
4. Monitor and analyse appropriate regulatory agency activities in areas of interest to the company and assess potential impact on programs. Able to take a global view on regulatory strategy and help teams navigate different regional requirements and the interplay between key regulatory agencies.
5. Interact with regulatory authorities, and outside consultants when needed.
6. Oversee and manage external regulatory and development vendor resources.
7. Prepare and lead a team through a regulatory meeting.
8. Write, review, and edit regulatory documentation, ensuring it is fit for purpose, and to serve as a resource for regulatory document authors regarding the appropriate content of submissions.
9. Reviews submissions to identify adequacy of sections, completeness and consistency of story and overall content of submissions, may be responsible for authoring submissions when needed
10. Communicates regulatory strategy effectively to all departments, senior management, regulators, and regulatory agencies to achieve time-lines

Education/Experience Requirements

• Degree qualified / advanced degree preferred.
• 7+ years’ Biotech/pharmaceutical experience in regulatory affairs in biologics.
• A solid knowledge of the drug development process, and European and USA regulations and guidelines pertaining to Cell Therapy and/or ADCs.
• Relevant experience across therapeutic areas in providing regulatory intelligence support to effectively facilitate strategic decision-making.
• Ability to work across several key projects.
  • Specialised knowledge that would be desirable and supportive of success in this position includes: Understanding of regulatory requirements for and hands on experience with submission of applications (e.g., INDs, NDAs, CTAs)
  • Extensive experience partnering with CROs on regulatory submission activities
  • Experience working on development programs and driving regulatory strategies specifically relating to clinical, pre-clinical and CMC aspects of the project.
  • Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
  • Experience in other key functional areas, (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research) appreciated
  • Experience in orphan drug development and understanding of EU/US regulations related to and orphan requirements
  • Demonstrated track record of success building relationships with, and influencing, regulatory agencies, particularly in situations requiring direct interaction/negotiation
  • Experience working in a global team environment.

Required Competencies – Knowledge, Skills & Abilities

Possesses a can-do, solutions-oriented attitude with the following specific skills:

• Strong Leadership skills
• Strong communication skills – excellent verbal and written communication
• Strong IT skills
• Excellent organisational and analytical skills and process oriented