Senior Manager, Regulatory Science - CMC

Location
Boston, MA, United States
Posted
Jul 09, 2021
Ref
125C75E00E
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
Location: US (East Coast); UK (London/Remote)

Reporting to: Senior 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
  • Provide Regulatory CMC support to Orchard Technical Operations and Chemistry, Manufacturing and Controls (CMC) teams in line with US, European, ICH, and other applicable regulatory requirements.
  • Participate in definition and implementation of Chemistry, Manufacturing and Controls (CMC) regulatory strategy for assigned program(s).
  • Participate on the assessment an communication of regulatory risks associated with assigned program(s).
  • Plan, prepare and submit high quality CMC modules of investigational and marketing authorization filings for Orchard's gene therapy products to major regulatory jurisdictions such as US, Europe and UK, in collaboration with partners from Technical Operations/CMC.
  • In collaboration with Technical Operations subject matter experts, support the preparation of responses to questions and requests for information from regulatory authorities.
  • Support CMC Regulatory intelligence activities as required.
  • Other activities as may be assigned.
  • Significant (4 - 6 years) regulatory CMC experience including program support. Experience in Biologics and/or Advanced Therapy Medicinal Products (ATMPs) is a plus.
  • Successful experience in supporting/independently leading Module 3 sections for investigational and marketing applications.
  • Good understanding of manufacturing, testing and regulation of pharmaceutical products.
  • Experience authoring CMC documents and supporting health authority communications.
  • Experience leading CMC-focused meetings is a must.
  • Experience with life cycle management activities is a plus.


Requirements

Required knowledge/experience

  • Significant (4 - 6 years) regulatory CMC experience including program support. Experience in Biologics and/or Advanced Therapy Medicinal Products (ATMPs) is a plus.
  • Successful experience in supporting/independently leading Module 3 sections for investigational and marketing applications.
  • Good understanding of manufacturing, testing and regulation of pharmaceutical products.
  • Experience authoring CMC documents and supporting health authority communications.
  • Experience leading CMC-focused meetings is a must.
  • Experience with life cycle management activities is a plus.
  • Ability to maintain high standards of professionalism and quality of work, including supporting/leading regulatory planning, preparation and submission of Module 3 related documents
  • Excellent oral and written communication skills.
  • Ability to prioritize and respond effectively to program changes.
  • Ability to work in a cross-functional team environment and with remote teams.
  • Strong attention to detail and the ability to handle multiple tasks.
  • Excellent organizational, computer and documentation skills.
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
  • M.S. or PhD in pharmacy, cell biology, pharmacology, bio/chemistry, bio/chemical engineering or closely related field.

Skills & Abilities

  • Ability to maintain high standards of professionalism and quality of work, including supporting/leading regulatory planning, preparation and submission of Module 3 related documents
  • Excellent oral and written communication skills.
  • Ability to prioritize and respond effectively to program changes.
  • Ability to work in a cross-functional team environment and with remote teams.
  • Strong attention to detail and the ability to handle multiple tasks.
  • Excellent organizational, computer and documentation skills.
Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
Education
  • M.S. or PhD in pharmacy, cell biology, pharmacology, bio/chemistry, bio/chemical engineering or closely related field.