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- Tasks: Lead regulatory activities for late-stage gene therapy programs, ensuring compliance and strategic alignment.
- Company: Join Orchard Therapeutics, a global leader in gene therapy dedicated to transforming lives through innovative treatments.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and collaboration across global teams.
- Why this job: Be part of groundbreaking science that impacts rare diseases and work with a passionate team in a vibrant culture.
- Qualifications: 7+ years in regulatory roles, strong knowledge of EMA guidelines, and experience with biologics or ATMPs required.
- Other info: Ideal for detail-oriented individuals who thrive in collaborative settings and are eager to make a difference.
The predicted salary is between 72000 - 108000 £ per year.
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.
Skills & Competencies
- 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.
Education
- M.S./M.Sc, Pharm. D. or PhD in chemistry, cell biology, molecular biology, pharmacology, pharmacy, bio/chemical engineering or closely related field.
Senior Manager, Regulatory Science Late-Stage Programs employer: Orchard Therapeutics
Contact Detail:
Orchard Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Regulatory Science Late-Stage Programs
✨Tip Number 1
Familiarise yourself with the latest EMA and MHRA guidelines, as well as any recent changes in regulations. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory science community, especially those who have experience with gene therapy products. Attend relevant conferences or webinars to make connections that could provide insights into the role and the company.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully managed regulatory submissions or led interactions with health authorities. Highlighting these achievements can set you apart from other candidates.
✨Tip Number 4
Showcase your ability to work collaboratively by preparing to discuss how you've effectively coordinated with cross-functional teams in previous roles. This is crucial for a position that requires alignment on development and registration strategies.
We think you need these skills to ace Senior Manager, Regulatory Science Late-Stage Programs
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 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 your ability to handle multiple tasks. Provide examples of how you've successfully managed regulatory submissions or led teams in previous roles.
Showcase Relevant Education: Ensure you mention your educational qualifications, particularly if you hold an M.S./M.Sc, Pharm. D., or PhD in a related field. This will reinforce your suitability for the role and your understanding of the scientific aspects of regulatory science.
How to prepare for a job interview at Orchard Therapeutics
✨Know Your Regulatory Framework
Make sure you have a solid understanding of the EMA and MHRA regulations, especially as they pertain to gene therapy. Brush up on recent changes in guidelines and be prepared to discuss how these might impact Orchard Therapeutics' late-stage programs.
✨Demonstrate Leadership Skills
As a Senior Manager, you'll need to showcase your ability to lead cross-functional teams. Prepare examples from your past experiences where you've successfully managed regulatory submissions or led interactions with health authorities.
✨Highlight Attention to Detail
Given the importance of accuracy in regulatory documents, be ready to discuss how you ensure high-quality submissions. Share specific strategies you use to maintain compliance and manage timelines effectively.
✨Showcase Collaborative Experience
Collaboration is key in this role. Be prepared to talk about how you've worked with diverse teams in the past, particularly in a regulatory context. Highlight any experience you have in coordinating with global teams to align on strategies.
