At a Glance
- Tasks: Lead regulatory activities for innovative gene therapy programs and manage submissions to authorities.
- Company: Join Orchard Therapeutics, a global leader in gene therapy dedicated to transforming lives.
- Benefits: Enjoy a full-time role with opportunities for collaboration and professional growth.
- Other info: This role is based in London and offers a chance to influence global regulatory strategies.
- Why this job: Be part of groundbreaking science that impacts rare diseases and work in a dynamic team environment.
- Qualifications: 7+ years in regulatory affairs, preferably with biologics or gene therapies; advanced degree required.
The predicted salary is between 54000 - 84000 £ per year.
Senior Manager, Regulatory Science Late-Stage Programs
Senior Manager, Regulatory Science Late-Stage Programs
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Location: London
Reporting to: Vice President, Regulatory Science
Job Summary
Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative cell and gene therapies. Orchard has its global headquarters in London and U.S. headquarters in Boston, and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.
This is a unique opportunity to join a team responsible for the development of global regulatory strategies and execution of regulatory activities for exciting late stage ex-vivo Gene Therapy assets. Late-stage assets encompass programs from the point of registrational clinical study initiation through approved programs. This position is ideal for someone with a solid regulatory background who can apply strong execution, collaboration, problem-solving, and attention to detail skills to contribute to groundbreaking science.
Key Responsibilities
Lead the execution of EU/UK regulatory activities by planning, preparing, reviewing and managing submissions to regulatory authorities (including EMA and EU/UK national authorities) for the assigned programs:
- Serve as the primary contact with regulatory authorities, leading interactions, preparing meeting materials, and responding to inquiries. Coordinate with global teams to ensure alignment on development and registration strategies. Attend cross-functional meetings and provide regulatory updates.
- Assess EMA/MHRA impact on development strategy and recommend actions to team leaders.
- Advise on EMA/MHRA interactions and filing timelines.
- Oversee regulatory maintenance for ongoing clinical trials and manage Clinical Trial Applications (CTA)-related submissions to national regulatory authorities in EU/UK.
- Prepare and submit annual reports for orphan designation (OD), and/or PRIME designation.
- Prepare and submit pediatric investigation plan (PIP) modifications to ensure compliance at the time of MAA. Prepare and submit scientific advice and pre-submission meetings requests and briefing documents.
- Act as lead to a multi-disciplinary team responsible for preparing and submitting MAA.
- Manage the life cycle of regulatory activities, including variations, renewals, and post-approval commitments.
- Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with defined timelines.
- Monitor, analyze, and disseminate intelligence on regulatory topics that may impact ongoing development programs or approved commercial products.
- Review internal SOPs and participate in internal audits and future HA inspections.
Experience & Knowledge
- Minimum of 7 years of regulatory experience, focused on the development of biologics and/or Advanced Therapy Medicinal Products (ATMPs) in the EU/UK.
- Strong knowledge and understanding of EMA, EU/UK national and global regulations and guidelines for drug development.
- Experience in regulatory submission project management.
- Successful experience in writing and reviewing regulatory filings (e.g. CTA, IND, MAA, BLA) for investigational and marketing applications for biotech/ATMP products.
- Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. scientific advice with pre-MAA interactions) or major filing (e.g. CTA).
- Experience with life cycle management activities in Europe and/or US is a plus.
- Experience in Gene Therapy Medicinal Products development and registration is a plus.
- Strong attention to details, ensuring high quality regulatory documents.
- Ability to establish and maintain a strong collaborative working relationship within the Regulatory team and with other functions, remote teams, and stakeholders.
- Capable of multitasking, planning, prioritizing, and adapting to changes in activities.
- Ability to motivate (lead the activity of) a sub-team/taskforce.
- Excellent organizational, computer and documentation skills.
- General interest in a broad range of Regulatory activities.
- M.S./M.Sc, Pharm. D. or PhD in chemistry, cell biology, molecular biology, pharmacology, pharmacy, bio/chemical engineering or closely related field.
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#J-18808-LjbffrSenior Manager, Regulatory Science Late-Stage Programs in London employer: Orchard Therapeutics plc
Orchard Therapeutics is an exceptional employer, offering a dynamic work environment in the heart of London, where innovation meets collaboration. Employees benefit from a strong focus on professional growth, with opportunities to lead groundbreaking projects in gene therapy while being part of a supportive team culture that values diverse perspectives and encourages continuous learning. With a commitment to transforming lives through cutting-edge science, Orchard provides a unique chance to make a meaningful impact in the field of rare diseases.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Regulatory Science Late-Stage Programs in London
✨Tip Number 1
Network with professionals in the regulatory science field, especially those who have experience with gene therapy and biologics. Attend industry conferences or webinars to meet potential colleagues and learn about the latest trends and challenges in regulatory affairs.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks of the EMA and MHRA, as well as any recent changes in guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 3
Prepare to discuss your previous experiences in leading regulatory submissions and interactions with health authorities. Be ready to share specific examples that highlight your problem-solving skills and ability to manage complex projects effectively.
✨Tip Number 4
Showcase your collaborative skills by discussing how you've worked with cross-functional teams in the past. Highlight instances where your contributions led to successful regulatory outcomes, as teamwork is crucial for this role at Orchard Therapeutics.
We think you need these skills to ace Senior Manager, Regulatory Science Late-Stage Programs in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights relevant regulatory experience, especially in biologics and Advanced Therapy Medicinal Products (ATMPs). Emphasise your familiarity with EMA and EU/UK regulations, as well as any specific achievements in regulatory submissions.
Craft a Compelling Cover Letter:In your cover letter, express your passion for gene therapy and how your background aligns with Orchard Therapeutics' mission. Mention specific experiences that demonstrate your ability to lead regulatory activities and collaborate with cross-functional teams.
Highlight Key Skills:Focus on skills such as attention to detail, project management, and the ability to motivate teams. Provide examples of how you've successfully managed regulatory submissions or led interactions with health authorities in the past.
Showcase Continuous Learning:Mention any ongoing education or training related to regulatory science or gene therapy. This could include certifications, workshops, or relevant courses that demonstrate your commitment to staying updated in the field.
How to prepare for a job interview at Orchard Therapeutics plc
✨Know Your Regulatory Framework
Make sure you have a solid understanding of the EMA and MHRA regulations, as well as the specific guidelines for Advanced Therapy Medicinal Products. Brush up on recent changes or updates in the regulatory landscape that could impact your role.
✨Demonstrate Leadership Skills
Be prepared to discuss your experience in leading cross-functional teams and managing regulatory submissions. Highlight specific examples where you successfully coordinated with global teams or led interactions with regulatory authorities.
✨Showcase Problem-Solving Abilities
Think of instances where you've faced challenges in regulatory processes and how you overcame them. Be ready to explain your thought process and the steps you took to ensure compliance and successful submissions.
✨Prepare for Technical Questions
Expect questions related to the specifics of regulatory submissions, such as CTAs, MAAs, and PIPs. Review your past experiences and be ready to discuss the details of your contributions to these processes.
