Senior Director, Regulatory Science CMC

Location: Remote US/Europe (Remote)

Reports to: VP, Regulatory Science CMC

Job Summary

Orchard is looking for a seasoned Regulatory CMC professional/leader to join the Regulatory Science CMC team for advancing its cell and gene therapy products through development, global regulatory approval and maintenance of commercial licensure. Reporting to the VP of Regulatory Sciences CMC, the individual will be accountable for developing and executing regulatory CMC strategies in collaboration with the Technical Operations and Regulatory Science departments. S/he is expected to continuously evaluate evolving regulatory CMC environment in the Advance Therapeutic Medicinal Product (ATMP) space, to provide strategic guidance to product development teams in a timely manner and provide managerial support/mentorship to junior regulatory CMC professionals in the team. This is a senior leadership position within the team with responsibility in delivering Orchard's regulatory CMC objectives at an exciting time in the company's history.

About Orchard 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 Science CMC leadership, guidance and inputs to Orchard Technical Operations teams in line with US, European, ICH, and other applicable regulatory requirements, while taking into consideration Orchard platform strategy
• Develop and direct regulatory CMC objectives and strategy for assigned program(s).
• Plan, author, review and submit high quality CMC modules of investigational and marketing authorization submissions for Orchard's cell and gene therapy products.
• Provide line management leadership and mentoring to Regulatory Science CMC staff and final approval for regulatory submissions on behalf of the department.
• Monitor, analyze, and disseminate intelligence on regulatory CMC topics that may impact regulatory status of ongoing development programs or approved commercial products.
• Regularly assess and communicate regulatory risks associated with assigned program(s) to program team(s) and senior management.
• Closely collaborate with colleagues in global Regulatory Science to successfully implement department vision and goals, and cross-functionally deliver on program(s) objectives.
• Other activities as may be assigned.

Requirements

Required knowledge/experience

• Significant (10 -12 years) regulatory CMC program leadership experience with biologics and/or Advanced Therapy Medicinal Products (ATMPs).
• Experience leading Regulatory CMC teams.
• Successful experience in independently leading Module 3 sections for investigational and global marketing applications for biotech/ATMP products (US/ EU).
• In-depth understanding of manufacturing and testing of biotechnology and/or ATMPs and related regulations.
• Successful experience communicating with leading health authorities, such as US FDA and EMA, including leading CMC-focused meetings.
• Ability to maintain high standards of professionalism and quality of work, including strategic regulatory planning, regulatory program management and oral/written communication.
• 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 chemistry, cell biology, pharmacology, pharmacy, bio/chemical engineering or closely related fields.

Skills & Abilities

• Ability to maintain high standards of professionalism and quality of work, including strategic regulatory planning, regulatory program management and oral/written communication.
• 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 chemistry, cell biology, pharmacology, pharmacy, bio/chemical engineering or closely related fields.

Education

• M.S. or PhD in chemistry, cell biology, pharmacology, pharmacy, bio/chemical engineering or closely related fields.