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Head of Regulatory Affairs

Everyone should have access to innovative therapies that represent the promise of lasting cures. At Theolytics we are working to transform patients’ lives, through world leading science, with a great team. Our discovery platforms harness the power of viruses to systematically identify therapies optimised for a chosen patient population, with a focus on oncology.

We are looking for a Head of Regulatory Affairs to join our team. This position represents an excellent opportunity for someone looking to take leadership responsibility in a fast paced environment, working within an interdisciplinary team to develop new cancer treatments. The role will include: contributing to the development of regulatory strategies across multiple programmes, leading the coordination of regulatory submissions, acting as the key regulatory contact for UK, EU and US health authorities, and managing third-party providers and consultants to deliver on strategic objectives.

Theolytics is committed to creating, inspiring and protecting a culture of inclusivity and diversity in everything we do. We bring our authentic selves to work, and strive to find and support the best person for any given role within our team. Our recruitment leads with capability, values and performance.
 

Activities

  • Define and develop regulatory strategies, ensuring that product manufacturing/CMC, non-clinical and clinical development plans are sound and comply with UK, Europe and USA regulatory requirements.

  • Plan, coordinate, write and review submissions and meetings with regulatory agencies.

  • Plan, coordinate, write and review regulatory submissions and reports including, but not limited to Investigational New Drug (IND/IMPD) and clinical trial applications (CTA) applications and  marketing authorization applications.

  • Respond to requests for information from regulatory bodies.

  • Provide regulatory development expertise and support for company strategy, as well as short and long-term operational planning.

  • Act as an in-house regulatory expert, advising and coordinating with other departments regarding production, design and development to ensure compliance with regulations.

  • Assist with the development of standards for the company's operating and production procedures.

  • Maintain current knowledge of regulatory legislation and guidelines applicable to the company and evaluate the effect that these changes will have on the company.

  • Develop and maintain professional relationships in UK, Europe and USA regulatory agencies. 

  • Oversee the selection, and quality oversight of CRO partners to maximize the value obtained from these partnerships, andreview performance, driving changes in partners if required.

  • Work towards validation of process, analytics and supply chain for product candidates.

  • All responsibilities and accountabilities listed for this role require execution in accordance with current UK, Europe and USA, ICH and GxP requirements.

Candidate Profile

Essential

  • An advanced degree (MD, PhD, PharmD or the equivalent expertise through experience).

  • Experience in regulatory affairs with UK/MHRA, European/EMA and FDA interactions, including  IND-IMPD/CTAs applications.

  • Experience with successful clinical and registration filings. 

  • Experience communicating with the health agencies and organising scientific advisory meetings such as Scientific Advice, INTERACT, pre-IND meetings.

  • Knowledge from working with the UK, EU and USA,  ICH and GXP requirements in different stages of development.

  • Full functional knowledge of regulatory requirements pertaining to the development and registration of biological viral drugs/gene therapy and/or oncology filings.

  • Track record of strategic thinking, weighing up risks and benefits to drive commercially sound decision making.

  • Exceptional interpersonal, communication, and management skills to collaborate with internal and external teams at all levels.

  • Self-motivated with strong initiative and willingness to take ownership and drive projects to

  • completion.

  • Excellent written and verbal communication skills, credible with internal colleagues, as well as external stakeholders.

  • Motivated, flexible, team player with the ability to work under time pressure and eager to learn and develop in a fast-paced, multiple pipeline-programme company.

 

Desirable 

  • Oncolytic virus, viral vector and/or gene therapy experience.

  • Understand emerging practices for adenoviral therapy manufacturing.

  • Project management experience with CDMO and fill-finish partners.

  • RAC and BLA experience.

  • Working knowledge of eCTD.

 

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