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- Tasks: Lead regulatory strategies and submissions for innovative cell and gene therapy programs.
- Company: Join CGT Catapult, a pioneer in accelerating cell and gene therapy development in the UK.
- Benefits: Enjoy a diverse and inclusive workplace with opportunities for personal and professional growth.
- Why this job: Make a real impact in the biotech field while collaborating with top experts and stakeholders.
- Qualifications: 3-5 years in regulatory affairs, ideally in cell/gene therapy or biologics.
- Other info: CGT Catapult values diversity and has received bronze accreditation from Inclusive Employers.
The predicted salary is between 45000 - 63000 £ per year.
The Regulatory Affairs Manager at CGT Catapult will act as a regulatory representative for CGT Catapult programmes.
- Implement optimal regulatory strategies for each programme in agreement with the Head of Regulatory Affairs/Senior Lead Regulatory Affairs, Chief Clinical Officer (CCO) and key stakeholders
- Compile and submit regulatory submissions, ensuring that they are delivered to agreed time, cost and quality standards
- To support the development programmes in place in CGT Catapult, providing expert advice to ensure the programmes are developed in a way which meet regulatory and quality requirements
- Implement optimal regulatory strategies for each programme in agreement with the Head of Regulatory Affairs/Senior Lead Regulatory Affairs, Chief Clinical Officer (CCO) and key stakeholders
- Compile and submit regulatory submissions, ensuring that they are delivered to agreed time, cost and quality standards
- To support the development programmes in place in CGT Catapult, providing expert advice to ensure the programmes are developed in a way which meet regulatory and quality requirements
Key Accountabilities:
- With the Head of Regulatory Affairs and/or Senior Lead Regulatory Affairs, develop an agreed CMC/ regulatory strategy and implementation plan for each programme
- Prepare regulatory documents (briefing documents, GMO submissions, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and agreed time, cost and quality standards
- To liaise closely with relevant departments of CGT Catapult and external Collaborators to ensure proposed developments (manufacturing and analytical) are fit for purpose and suitably planned whilst ensuring the development programme will meet regulatory and quality requirements
- Ensure appropriate regulatory due diligence is carried out on all incoming propositions and external facing proposals
- Maintain up to date knowledge of development in regulations, guidelines, CMC, GCP and GMP requirements for cell and gene therapy products
- Develop and maintain constructive working relationships with regulatory agency and health authority contacts, contributing to strategies to influence regulators as required towards appropriate risk evaluation and management
Experience:
- Approximately 3-5 years or more regulatory affairs experience, ideally with 1-2 years in a cell and/or gene therapy environment or, at a minimum, with some experience in the regulation of biologic or biotech products
- Proven experience of working independently in the drafting and delivery of high-quality regulatory documents
Knowledge / Skills / Competencies:
- Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UK
- Desire to establish a high-profile career within cell and gene sector and the personal drive to help push the sector to be a commercial success
- Knowledge of US regulatory frameworks (Advantageous)
- Working knowledge of EU GMP and tissues and cells legislation (Advantageous)
- Proven ability to evaluate and implement efficient regulatory strategies and manage complex regulatory issues including areas of biotechnology, biological therapies and preferably, cell and gene therapy
- Ability to lead the quality and regulatory aspects of the development strategy for assigned CGT Catapult Programmes
- Demonstrable regulatory leadership of CTA /IND processes as well as experience of scientific advice meetings with Regulatory Authorities is an advantage
- Proven ability to consistently deliver to time, cost and quality standards
- Can be counted on to deliver tasks, planning effectively and managing time to cope with the unexpected
- Applies technical expertise/practical experience and shares knowledge with others to continuously improve; provides opportunities to involve others in projects by listening, collaborating and influencing to create wider impact
- Proposes solutions and seeks advice to gets things done.
- Builds trust and credibility with others through clear communication, pursues and secure buy-in from a range of people
- Understands the importance of working together and aligns abilities and goals with those of the team
- Navigates ambiguity well and learns from experiences; demonstrate resilience when coping with challenges
- Actively seeks to understand, question and listen to others to improve effectiveness to benefit the team and division
- Open to feedback and confident to deliver constructive feedback with the intent of learning and developing themselves and others
- High level interpersonal, communication (oral and written) skills and emotional intelligence
- A “roll your sleeves up” hands-on attitude towards varying work assignments
- Project ownership and pride in its delivery
- Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks
- Ambitious, collaborative, driven
- Comfortable operating autonomously once goals and objectives are set
- Able to evaluate complex situations and find solutions for them in a professional manner
- Accurate with strong attention to detail
- High degree of motivation, problem solving skills and innovative thinking
- A positive attitude towards learning, personal and professional development
- Keeps up to date with professional knowledge, expertise and best practice
- Willingness to travel
Education / Qualifications:
- Higher degree or at a minimum graduate in a life science subject.
CGT Catapult is committed to providing an equal, diverse, and inclusive work environment where everyone’s contributions are valued. We celebrate differences, empower, and inspire everyone, because when everyone is included, everyone wins. In 2024, we received bronze accreditation from Inclusive Employers.
Regulatory Affairs Manager (12-15 Month FTC) employer: Cell and Gene Therapy Catapult
Contact Detail:
Cell and Gene Therapy Catapult Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager (12-15 Month FTC)
✨Tip Number 1
Familiarize yourself with the latest regulations and guidelines specific to cell and gene therapy. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience in cell and gene therapy. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends and challenges.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully navigated complex regulatory issues in your past roles. Highlight your ability to develop and implement effective regulatory strategies that align with business needs.
✨Tip Number 4
Showcase your interpersonal and communication skills during the interview process. Being able to build constructive relationships with regulatory agencies and internal stakeholders is crucial for this role, so be ready to provide examples of how you've done this in the past.
We think you need these skills to ace Regulatory Affairs Manager (12-15 Month FTC)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant regulatory affairs experience, especially in cell and gene therapy. Use specific examples that demonstrate your ability to develop and implement regulatory strategies.
Craft a Strong Cover Letter: In your cover letter, express your motivation for the role and how your skills align with the key accountabilities listed in the job description. Mention your experience with regulatory submissions and your knowledge of relevant regulations.
Highlight Relevant Experience: Clearly outline your experience in drafting high-quality regulatory documents and any previous roles where you liaised with regulatory agencies. This will show your capability to manage complex regulatory issues.
Showcase Soft Skills: Emphasize your interpersonal and communication skills, as well as your ability to work under pressure and navigate ambiguity. These traits are crucial for the collaborative environment at CGT Catapult.
How to prepare for a job interview at Cell and Gene Therapy Catapult
✨Show Your Regulatory Expertise
Make sure to highlight your experience in regulatory affairs, especially in the context of cell and gene therapy. Be prepared to discuss specific regulatory documents you've worked on, such as CTAs or INDs, and how you ensured they met quality standards.
✨Demonstrate Strategic Thinking
Discuss how you have developed and implemented regulatory strategies in previous roles. Provide examples of how you collaborated with key stakeholders to align on regulatory approaches and how you navigated complex regulatory issues.
✨Communicate Effectively
Strong communication skills are crucial for this role. Practice articulating your thoughts clearly and concisely, both in writing and verbally. Be ready to explain how you build relationships with regulatory agencies and influence their decisions.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world scenarios. Think about past challenges you've faced in regulatory affairs and how you approached them. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
