Facilities & Compliance Coordinator overseeing maintenance and compliance tasks at Solvd.'s Glasgow office. Ensuring safety standards and efficient operations through effective management and oversight.
About the role
- Director of Regulatory Science at Orchard Therapeutics guiding global regulatory strategies for gene therapies. Leading cross-functional collaboration and regulatory compliance initiatives for new medicinal products.
Responsibilities
- Act as the __Global Regulatory Lead__ on assigned ex vivo gene therapy program(s):
- Represent the regulatory function on related cross-functional program team(s)
- 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)
- Own the development of global regulatory strategies and the execution of all planned regulatory activities globally (i.e. 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
- Provide oversight on US FDA regulatory activities with a view to achieve global development and registration in coordination with US colleagues
- Collaborate closely with the Reg CMC lead for the development of successful regulatory strategy associated with the CMC development
- Regulatory liaison with academic partners and coordination of regulatory activities with them as appropriate.
- Act as __EU/UK Regulatory Regional Lead__, leading the execution of EU/UK regulatory activities for the assigned programs:
- Plan, prepare, and review submissions to regulatory authorities (including EMA and other national authorities):
- 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
- Applications for orphan designation (OD), PRIME designation, scientific advices, paediatric investigation plan (PIP), presubmission meetings, etc.
- Serve as the primary liaison with regulatory authorities
- Prepare scientific advice/pre-submission meetings requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities
- Coordinate and prepare responses to questions, requests for information from regulatory authorities
- Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with defined timelines.
- Actively participate in __regulatory compliance__ and __regulatory team development__:
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
- 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
- Contribute to updates, improvements and development of processes (including new SOPs as applicable) linked to regulatory activities
- Participate in internal audits and future HA inspections
- Mentor junior regulatory affairs personnel
- Share expertise and learning experiences - “grow together” approach within the regulatory team.
Requirements
- M.S./M.Sc, 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)
- 12+ years of experience in regulatory science applied to the development and registration of new medicinal products in the EU, UK and globally
- Knowledge and experience of development / registration of biologics and/or Advanced Therapy Medicinal Products (ATMPs) is preferred
- Strong knowledge and understanding of EMA, EU/UK national and global regulations and guidelines for drug development is a must
- Experience in regulatory submission project management
- Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. scientific advice with EMA, PRIME, other pre-MAA interactions) and major filing (e.g. CTA/IND, MAA)
- Knowledge and understanding of global development/filing of an orphan medicinal product is a plus
- Strong attention to details, translating into ability to produce high quality regulatory documents.
- Proven ability to direct the resolution of complex issues that impact success or address future processes/outcomes.
- Ability to establish and maintain a positive, strong and efficient collaborative working relationship within the Regulatory team and with other functions and stakeholders
- Ability to handle multiple tasks in parallel in a fast-paced environment; ability to plan, prioritize and respond effectively to program/activities changes.
- Ability to develop partnerships that support a strong cross-functional and inclusive team environment
- Ability to work in autonomy on allocated programs
- Ability to motivate (lead the activity of) a sub-team/taskforce.
- Excellent organizational, computer and documentation skills.
- Solution-oriented approach to problem-solving including assessing variables, evaluating fundamental issues, anticipating business impact and providing direction.
- General interest in a broad range of Regulatory activities.
- Strong interpersonal skills including verbal and written communication.
Job title
Job type
Experience level
Salary
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Degree requirement
Location requirements
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