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Senior Regulatory Affairs Manager

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 (www.theolytics.com).

We are looking for a Senior Regulatory Affairs Manager 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

  • 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.

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

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

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

  • 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 CRO partners to maximise the value obtained from these partnerships, and review performance.

  • 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

  • BSc / Msc / PhD/ MD / PharmD or the equivalent expertise through experience.

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

  • Experience communicating with the health agencies and organising scientific advisory meetings.

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

  • Knowledge from working with the UK, EU and USA,  ICH and GXP requirements.

  • Full functional knowledge of regulatory requirements pertaining to the development of biological and oncology filings.

  • 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.

  • 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

 

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