Associate Director, Regulatory Affairs CMC in Cambridge

The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager’s gene therapy products.

These responsibilities will be in line with corporate objectives and are to be achieved in coordination with key internal and external team collaboration partners.

The qualified candidate will define Regulatory CMC submission strategies and plan, construct, direct, write summaries/reports for CMC sections of INDs, CTAs, BLAs and MAAs including post-approval supplemental applications and coordinate responses during the review/approval by Regulatory authorities.

This role will also be responsible for the content of the CMC section of briefing documents for pre-IND, End of Phase 2, and pre-BLA meetings in the US and scientific advice in the EU plus supporting CMC materials for meetings with PMDA in Japan.

Ensure accuracy of CMC requirements for validated analytical testing and manufacturing of Phase 3 material, including commercial product specifications are met according to Health authority requirements and expectations to efficiently progress clinical trials, submissions and approvals on a global basis.

During health authority inspections, the Associate Director of Regulatory CMC will provide relevant documentation, support and rationale concerning Regulatory CMC submissions.

This position reports to the Senior Vice President of Regulatory Affairs and Quality Assurance and is located in Cambridge, MA.

Responsibilities

• Provide innovative and proactive regulatory strategy for CMC development of gene therapy products for all project teams in early research and all stages of clinical development.
• Design and execute an effective global regulatory CMC strategy in alignment with the overall development plan and corporate goals that will meet all Health authority regulations and support registration and approval.
• Work closely internally and with Alliance partners in Manufacturing and Quality Assurance including other disciplines to prepare and execute global submissions addressing the needs of each partner.
• Lead, supervise and author all CMC sections of submissions throughout the product’s life cycle, including briefing documents, INDs, and various Health authority requests for additional information.
• Prepare the team and lead negotiations with FDA and other health agencies regarding all manufacturing questions.

The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager’s gene therapy products.

These responsibilities will be in line with corporate objectives and are to be achieved in coordination with key internal and external team collaboration partners.

The qualified candidate will define Regulatory CMC submission strategies and plan, construct, direct, write summaries/reports for CMC sections of INDs, CTAs, BLAs and MAAs including post-approval supplemental applications and coordinate responses during the review/approval by Regulatory authorities.

This role will also be responsible for the content of the CMC section of briefing documents for pre-IND, End of Phase 2, and pre-BLA meetings in the US and scientific advice in the EU plus supporting CMC materials for meetings with PMDA in Japan.

Ensure accuracy of CMC requirements for validated analytical testing and manufacturing of Phase 3 material, including commercial product specifications are met according to Health authority requirements and expectations to efficiently progress clinical trials, submissions and approvals on a global basis.

During health authority inspections, the Associate Director of Regulatory CMC will provide relevant documentation, support and rationale concerning Regulatory CMC submissions.

This position reports to the Senior Vice President of Regulatory Affairs and Quality Assurance and is located in Cambridge, MA.

Responsibilities

• Provide innovative and proactive regulatory strategy for CMC development of gene therapy products for all project teams in early research and all stages of clinical development.
• Design and execute an effective global regulatory CMC strategy in alignment with the overall development plan and corporate goals that will meet all Health authority regulations and support registration and approval.
• Work closely internally and with Alliance partners in Manufacturing and Quality Assurance including other disciplines to prepare and execute global submissions addressing the needs of each partner.
• Lead, supervise and author all CMC sections of submissions throughout the product’s life cycle, including briefing documents, INDs, and various Health authority requests for additional information.
• Prepare the team and lead negotiations with FDA and other health agencies regarding all manufacturing questions.

Qualifications

• Bachelor of Science Degree and relevant experience, or MS, Ph D degree preferred.
• Minimum 10 years experience working in Regulatory Affairs; ideally 7 plus years in the biotech industry (gene therapy, monoclonal antibodies, vaccines, blood products, and/or cell products) including preferably experience in a small biotech company environment
• Sound depth of knowledge and expertise in Regulatory Affairs, including all associated requirements
• Pharmaceutical industry experience in successfully transitioning from Phase 1 clinical trial material to Phase 3 and commercial GMP quality material with a record of successful product approval in the US, EU, Asia and pre-approval inspection success.
• Deep experience interfacing with the FDA and other Health authorities.
• Gene therapy experience a plus

Skills /Competencies

• Extensive knowledge and understanding of global regulatory requirements for CMC and GMO environment.
• Demonstrated strategic thinking and problem-solving for CMC issues in the rapidly developing field of manufacturing gene therapy products.
• Must be detail-oriented, possess good analytical testing knowledge, including problem-solving skills.
• Must have excellent verbal and written communication skills, including strong interpersonal skills.
• Ability to work independently with minimal supervision, and to take ownership and responsibility.
• Ability to work cooperatively and influence, internal cross-functional teams including alliance partners
• Results focused with the ability to perform under pressure and meet deadlines.
• Ability to win respect and gain credibility within the company and with alliance partners.
• Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities.
• Alignment with Voyager’s Core Values
• Travel Expectations: Travel both Domestic/International: 10-15%

Skills & Requirements

Qualifications

• Bachelor of Science Degree and relevant experience, or MS, Ph D degree preferred.
• Minimum 10 years experience working in Regulatory Affairs; ideally 7 plus years in the biotech industry (gene therapy, monoclonal antibodies, vaccines, blood products, and/or cell products) including preferably experience in a small biotech company environment
• Sound depth of knowledge and expertise in Regulatory Affairs, including all associated requirements
• Pharmaceutical industry experience in successfully transitioning from Phase 1 clinical trial material to Phase 3 and commercial GMP quality material with a record of successful product approval in the US, EU, Asia and pre-approval inspection success.
• Deep experience interfacing with the FDA and other Health authorities.
• Gene therapy experience a plus

Skills /Competencies

• Extensive knowledge and understanding of global regulatory requirements for CMC and GMO environment.
• Demonstrated strategic thinking and problem-solving for CMC issues in the rapidly developing field of manufacturing gene therapy products.
• Must be detail-oriented, possess good analytical testing knowledge, including problem-solving skills.
• Must have excellent verbal and written communication skills, including strong interpersonal skills.
• Ability to work independently with minimal supervision, and to take ownership and responsibility.
• Ability to work cooperatively and influence, internal cross-functional teams including alliance partners
• Results focused with the ability to perform under pressure and meet deadlines.
• Ability to win respect and gain credibility within the company and with alliance partners.
• Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities.
• Alignment with Voyager’s Core Values
• Travel Expectations: Travel both Domestic/International: 10-15%