Senior Director, CMC Regulatory Science

Location
London, United Kingdom
Posted
Sep 11, 2020
Ref
35FC729C05
Required Education
Masters Degree/MBA
Position Type
Full time

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 CMC regulatory contact to internal parties and regulatory bodies
  • Participate in definition and implement CMC regulatory strategy for path to approval
  • Plan, prepare, and review submissions, incl. CMC/quality sections to regulatory authorities (including FDA, EMA and other national authorities) to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA)
  • Lead CMC regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
  • Work closely with CMC functional groups (mainly located in San Francisco Area - US), contract manufacturing Organisations and other Regulatory Colleagues 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 and necessary tech transfers while ensuring conditions for meeting regulatory requirements are maintained
  • Be responsible for maintaining up to date knowledge of CMC regulatory requirements and communicate changes in regulatory information to project teams and senior management in a timely manner.
  • Facilitate good communication and transparency of CMC regulatory information to relevant functions
  • Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
  • Coordinate and prepare responses to questions, requests for information from regulatory authorities
  • Monitor, analyze, and disseminate intelligence on CMC regulatory matters that may affect ongoing development programs or approved products
  • Line manage, train and mentor other CMC regulatory science personnel
  • Other activities as may be assigned


Requirements

Required knowledge

 

  • Extensive regulatory affairs industry experience
  • Significant CMC regulatory 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 would be a plus


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 remove 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 Authorities
  • Regulatory Affairs Certification would be a plus


Education

 

 

 

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