- 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.
- Bachelor of Science Degree and relevant experience, or MS, PhD 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
- 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%
-
Director, Regulatory Affairs Vaccines Cmc
3 weeks ago
ARIAD Boston, United States**Pay Range**: · $169, $266,200.00 · **Job ID** R0120763**Date posted** 04/16/2024**Location** Boston, Massachusetts**Pay Range** $169, $266,200.00**About the role**: · At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transfor ...
-
Manager, Regulatory Affairs CMC
6 days ago
Takeda Development Center Americas, Inc San Francisco, United States PermanentTakeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs · CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Globa ...
-
Manager, Regulatory Affairs CMC
2 weeks ago
Takeda Development Center Americas, Inc Cambridge, United StatesTakeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs · CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Globa ...
-
Director, CMC Regulatory Affairs
3 weeks ago
Sarepta Therapeutics Cambridge, United StatesLead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the primary interface with multiple internal and external stakeholders, including partners. Works as Global Regul ...
-
Director, CMC Regulatory Affairs
3 weeks ago
Alkermes Watertown, United StatesJob Description · Overview: · Great Science. Deep Compassion. Real Impact. · Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. · We are inspired by the cour ...
-
Director, CMC Regulatory Affairs
3 weeks ago
Alkermes Waltham, United States Full timeOverview: · Great Science. Deep Compassion. Real Impact. · Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. · We are inspired by the courage and determinatio ...
-
Regulatory Affairs Cmc Officer
3 weeks ago
Cytiva Marlborough, United States**Be part of something altogether life-changing** · Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative ...
-
Director, Regulatory Affairs Vaccines CMC
3 weeks ago
Takeda Boston, United StatesAbout the role: · At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possi ...
-
Manager, Regulatory Affairs CMC
4 weeks ago
Takeda Boston, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
-
Senior Manager, Regulatory Affairs CMC
3 weeks ago
Sarepta Therapeutics Cambridge, United StatesThe Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA workin ...
-
Associate Director Regulatory Affairs CMC
3 weeks ago
PSG Global Solutions Cambridge, United StatesWe're looking for an · Associate Director Regulatory Affairs CMC , working in · Pharmaceuticals · and · Medical Products · industry in · Cambridge, Massachusetts, United States . · Leads development and execution of robust global regulatory CMC strategy for assigned progra ...
-
Vice President, Regulatory Affairs, CMC
1 week ago
Ultragenyx Somerville, United StatesWhy Join Us?Be a hero for our rare disease patients · At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease ...
-
Senior Director, Regulatory Affairs CMC
4 weeks ago
Alexion Pharmaceuticals Boston, MA, United StatesThis is what you will do:The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RA-CMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cy ...
-
Manager/Senior Manager, CMC Regulatory Affairs
3 weeks ago
Alkermes Watertown, United StatesJob Description · Great Science. Deep Compassion. Real Impact. · Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. · We are inspired by the courage and dete ...
-
Manager, Global Regulatory Affairs CMC
2 days ago
Takeda Pharmaceutical Company Ltd Boston, MA, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
-
Director, Regulatory Affairs Vaccines CMC
3 weeks ago
Takeda Boston, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
-
Director, CMC Regulatory Affairs
3 weeks ago
Alkermes Waltham, United StatesJob Description · Overview: · Great Science. Deep Compassion. Real Impact. · Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. · We are inspired by the cou ...
-
Manager, Global Regulatory Affairs CMC
2 weeks ago
Takeda Boston, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
-
CMC Regulatory Affairs Specialist
2 days ago
Spectraforce Technologies Inc Bridgewater, United States PermanentJob title: CMC Regulatory Technical Writer II · Location: Bridgewater, NJ, Hybrid · Duration: 1 year · SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri · Pay Rate starts: $47/ HOUR · HM Notes: · Hybrid - onsite Tuesday & Thursday - This can change at any time. · 5 years exper ...
-
Regulatory Affairs CMC Officer
2 weeks ago
Cytiva Marlborough, MA, United States Full timeBe part of something altogether life-changing · Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vac ...
Associate Director, Regulatory Affairs CMC - Cambridge, United States - Voyager Therapeutics, Inc.
Description
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
Qualifications