Senior Manager, Regulatory Science Late-Stage Programs
Senior Manager, Regulatory Science Late-Stage Programs
4 weeks ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
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.
Pre-Approval Activities
* 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.
Post Approval Activities
* Manage the life cycle of regulatory activities, including variations, renewals, and post-approval commitments.
Other General Responsibilities
* 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.
Requirements
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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Other
Referrals increase your chances of interviewing at Orchard Therapeutics - U.S. by 2x
Get notified about new Senior Regulatory Manager jobs in London, England, United Kingdom.
London, England, United Kingdom 1 week ago
Senior Regulatory Compliance Manager and UK MLRO
London, England, United Kingdom 1 month ago
London, England, United Kingdom 5 days ago
Slough, England, United Kingdom 3 days ago
Global Regulatory Affairs Manager – Biopharma
Senior Manager, Global Regulatory Affairs
Greater London, England, United Kingdom 3 weeks ago
Associate Director, Regulatory Affairs, EMEA
London, England, United Kingdom 1 week ago
London, England, United Kingdom 1 week ago
Global Regulatory Affairs Manager (Global Program Regulatory Manager)
London, England, United Kingdom 4 hours ago
Senior Manager, Regulatory Communications Lead
London, England, United Kingdom 3 days ago
Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)
London, England, United Kingdom 4 hours ago
Uxbridge, England, United Kingdom 1 week ago
London, England, United Kingdom 3 weeks ago
London, England, United Kingdom 3 weeks ago
Head of Compliance & MLRO – Private Equity
Associate Director- Regulatory Scientific Affairs -EMEA
Erith, England, United Kingdom 1 week ago
London, England, United Kingdom 2 days ago
Regulatory Affairs and Quality Assurance (RAQA) Manager
London, England, United Kingdom 4 weeks ago
Senior Regulatory Product Compliance Manager - Wise Platform
London, England, United Kingdom 2 weeks ago
Regulatory Compliance Senior Manager (12 month FTC)
London, England, United Kingdom 2 weeks ago
Stratford, England, United Kingdom 4 days ago
London, England, United Kingdom 3 days ago
Associate Regulatory Affairs Manager (12 Month Fixed Term Contract)
Hatfield, England, United Kingdom 2 weeks ago
Job Posting Title Global Regulatory Affairs Manager (Global Program Regulatory Manager)
London, England, United Kingdom 4 hours ago
Woking, England, United Kingdom 2 months ago
London, England, United Kingdom 1 month ago
Senior Regulatory Reporting Implementation Specialist
London, England, United Kingdom £50,000.00-£90,000.00 1 month ago
London, England, United Kingdom 6 days ago
London, England, United Kingdom 3 days ago
Senior Manager Regulatory Affairs CMC Biosimilars
Regulatory Documents and Policies Manager – Retail Banking
Senior Manager, Regulatory Compliance Audit
London, England, United Kingdom 2 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr