Director/Senior Director Regulatory Science CMC

Location: London, UK

Reporting to: Sr. Director, Regulatory Science CMC

Job summary

Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases.

Key Elements and Responsibilities

• Serve as in-house regulatory CMC contact to internal parties and regulatory bodies.
• Participate in definition and implementation of CMC regulatory strategy, notably for Life-cycle management of Orchard's commercial and late-stage development products.
• Plan, author, and review, in collaboration with Tech Ops teams quality sections of dossiers to be submitted to regulatory authorities (including FDA, EMA and other national authorities) to support life cycle management of late-stage development and commercial products.
• Lead regulatory CMC activities for assigned projects in line with US, European, ICH, and other applicable requirements
• Work closely with internal Orchard Tech Ops functional groups and those at Contract manufacturers (CDMOs) to plan and produce high quality regulatory submissions while meeting aggressive timelines.
• Understand the development, formulation and testing processes of the different Orchard's products and provide relevant regulatory guidance and advice in a timely manner to expedite the manufacturing process changes and necessary technology transfers while ensuring conditions for meeting regulatory requirements are maintained
• Be responsible for maintaining up to date knowledge of regulatory CMC requirements and communicate changes in regulatory information to project teams and senior management in a timely manner.
• Facilitate good communication and transparency of regulatory CMC information to relevant TechOps functions and Regulatory CMC colleagues.
• Work with TechOps team to ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
• Coordinate and prepare responses to questions and requests for information from regulatory authorities
• Monitor, analyze, and disseminate intelligence on regulatory CMC matters that may affect ongoing development programs or approved products
• Line manage, train and mentor other regulatory CMC personnel
• Collaborate with global Regulatory CMC and Regulatory Science colleagues to successfully implement department vision and goals.
• Other activities as may be assigned

Requirements

Required knowledge

Extensive regulatory affairs industry experience

Experience with life cycle management

Significant regulatory CMC experience with demonstrable knowledge of the manufacturing and regulation of biotechnology and gene therapy products for human use

Successful experience writing CMC documents that comply with regulatory requirements is a must.

Skills & Abilities

Ability to maintain high standards of professionalism, quality, and prioritization

Ability to work in a cross-functional team environment with experience managing people and project teams; ability to work with remote team

Strong attention to detail and the ability to handle multiple tasks

Excellent organizational, computer and documentation skills and an ability to prioritize effectively

Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment and to interact efficiently with regulatory authorities

Regulatory Affairs Certification would be a plus

Education

M.S. or PhD in chemistry, cell biology, pharmacology, pharmacy or closely related field