Location: London, UK
Reporting to: VP, Regulatory Science
Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its headquarters in Boston, Massachusetts.
Job Summary
This a unique opportunity to join a team responsible for the development of global regulatory strategy and execution of regulatory activities for exciting early stage ex-vivo Gene Therapy assets. This position is ideal for someone with a solid regulatory background who can develop innovative regulatory strategies and apply strong execution, collaboration, problem-solving, and attention to detail skills to contribute to groundbreaking science.
Key Responsibilities
1. Act as the Global Regulatory Lead on assigned ex vivo gene therapy program(s):
2. Represent the regulatory function on related cross-functional program team(s)
3. Partner with the program lead and development team (research, preclinical, and/or clinical depending on the stage of the program) to build development strategy intended to support regulatory approval(s)
4. Own the development of global regulatory strategies and the execution of all planned regulatory activities globally ( including but not limited to EU and US) in partnership with the broader program regulatory team, leading to timely pivotal study initiation and allowing expedited path to approval
5. Provide oversight on US FDA regulatory activities with a view to achieve global development and registration in coordination with US colleagues
6. Collaborate closely with the Reg CMC lead for the development of successful regulatory strategy associated with the CMC development
7. Regulatory liaison with academic partners and coordination of regulatory activities with them as appropriate.
8. Act as EU/UK Regulatory Regional Lead, leading the execution of EU/UK regulatory activities for the assigned programs:
9. Plan, prepare, and review submissions to regulatory authorities (including EMA and other national authorities):
10. Manage or oversee initial clinical trial applications (CTA) to national regulatory authorities in EU/UK and subsequent submissions required for the maintenance of ongoing clinical trials, in collaboration with CROs
11. Applications for orphan designation (OD), PRIME designation, scientific advices, paediatric investigation plan (PIP), presubmission meetings, etc.
12. Serve as the primary liaison with regulatory authorities
13. Prepare scientific advice/pre-submission meetings requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities
14. Coordinate and prepare responses to questions, requests for information from regulatory authorities
15. Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with defined timelines.
16. Actively participate in regulatory compliance and regulatory team development:
17. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
18. Lead the implementation of new EU/UK regulations/guidelines applicable and relevant to development programs in close collaboration with the Global Regulatory Lead(s) and relevant functional leads
19. Contribute to updates, improvements and development of processes (including new SOPs as applicable) linked to regulatory activities
20. Participate in internal audits and future HA inspections
21. Mentor junior regulatory affairs personnel
22. Share expertise and learning experiences - “grow together” approach within the regulatory team.
Requirements
Education/Key Competencies
23., Pharm. D. or PhD in chemistry, cell biology, molecular biology, pharmacology, pharmacy, bio/chemical engineering or closely related field (Regulatory Affairs certification is a plus)
24. 12+ years of experience in regulatory science applied to the development and registration of new medicinal products in the EU, UK and globally
25. Knowledge and experience of development / registration of biologics and/or Advanced Therapy Medicinal Products (ATMPs) is preferred
26. Strong knowledge and understanding of EMA, EU/UK national and global regulations and guidelines for drug development is a must
27. Experience in regulatory submission project management
28. Previous experience in attending and leading a team to prepare for major health authority interactions ( scientific advice with EMA, PRIME, other pre-MAA interactions) and major filing ( CTA/IND, MAA)
29. Knowledge and understanding of global development/filing of an orphan medicinal product is a plus
30. Strong attention to details, translating into ability to produce high quality regulatory documents.
31. Proven ability to direct the resolution of complex issues that impact success or address future processes/outcomes.
32. Ability to establish and maintain a positive, strong and efficient collaborative working relationship within the Regulatory team and with other functions and stakeholders
33. Ability to handle multiple tasks in parallel in a fast-paced environment; ability to plan, prioritize and respond effectively to program/activities changes.
34. Ability to develop partnerships that support a strong cross-functional and inclusive team environment
35. Ability to work in autonomy on allocated programs
36. Ability to motivate (lead the activity of) a sub-team/taskforce.
37. Excellent organizational, computer and documentation skills.
38. Solution-oriented approach to problem-solving including assessing variables, evaluating fundamental issues, anticipating business impact and providing direction.
39. General interest in a broad range of Regulatory activities.
40. Strong interpersonal skills including verbal and written communication.
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.
We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
RECRUITERS
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.