Eraps B. V

Garuda Therapeutics is a unique, well-funded, privately held Start-Up that is developing off-the-shelf hematopoietic stem cell (HSC) therapies to treat a broad range of severe and life-threatening diseases is seeking a highly motivated individual to manage and lead their programs.. The Director/Vice President Regulatory affairs for iPSC derived cell therapies will manage the execution of global regulatory strategies for investigational and marketed cell and gene therapy products.. Leads the development of global CMC regulatory strategies for multiple investigational and/or marketed products. Manages individuals within Regulatory CMC to ensure robust and aligned CMC regulatory guidance is provided to cross-functional teams and key stakeholders. Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field

regulatory

Job Description Job Description Director/Vice President Regulatory Affairs (iPSC-Derived Cell Therapies) Location: 215 First Street, Cambridge, MA
Onsite / Hybrid
Reports to Chief Regulatory Officer Company Overview Garuda Therapeutics is a unique, well-funded, privately held Start-Up that is developing off-the-shelf hematopoietic stem cell (HSC) therapies to treat a broad range of severe and life-threatening diseases is seeking a highly motivated individual to manage and lead their programs. Our culture is based on collaboration, equal accountability and a healthy sense of humility Job Description The Director/Vice President Regulatory affairs for iPSC derived cell therapies will manage the execution of global regulatory strategies for investigational and marketed cell and gene therapy products. This role is accountable for the preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational thru to eventual marketed products. This is a leadership role within Regulatory CMC responsible for leading non-clinical regulatory CMC activities along with building out a future staff. Key Duties and Responsibilities:
Oversees the preparation and review of CMC sections of regulatory submissions, and leads the interactions and responses with regulatory agencies
Leads the development of global CMC regulatory strategies for multiple investigational and/or marketed products
Manages individuals within Regulatory CMC to ensure robust and aligned CMC regulatory guidance is provided to cross-functional teams and key stakeholders
Leads the design, development and implementation of department strategies and contributes to the strategic planning for the area
Ensures assigned projects are appropriately resourced and is accountable for the results of the team
As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff. Knowledge and Skills:
Excellent interpersonal skills to influence others internally and/or externally and to negotiate with others in a limited capacity
Advanced strategic thinking and problem-solving skills
Collaborates and communicates in an open, clear, complete, timely, and consistent manner
Strong sense of planning and prioritization, and the ability to work with all levels of management
Experience working with cell or gene therapies is desired but not a requirement
A minimum of 5 years expertise working in biologics is required.
Comprehensive knowledge of regulatory (FDA. EMA, Health Canada and ICH) guidelines
Experience with development and/or improvement of department processes/procedures
Proven ability to impact and influence the decisions of a team and decision-making committees
Strong experience managing technical individuals Education and Experience:
Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
Must have recent/current experience working in cellular therapy pipeline within regulatory CMC
Typically requires 10 years of experience in the pharmaceutical or biotech industry or in a related field and 3 years of supervisory/management experience, or the equivalent combination of education and experience About Garuda Therapeutics:
Garuda Therapeutics seeks to create a world that eliminates the dependency on donor or patient cells for blood stem cell transplants. Our platform technology for generating off-the-shelf, self-renewing blood stem cells is poised to provide patients with rapid and broad access to consistent, durable, HLA-compatible and transgene-free blood stem cell therapies. Like bone marrow transplants, our technology could provide potentially curative therapies for more than 70 diseases.https://garudatx.com/ If you are interested in applying for this position, please contact:
Brandan Sweeney
Executive Regulatory Search Consultant
ERAPS, LLC
(617) 500-2510
bsweeney@eraps.bio #J-18808-Ljbffr

START NEW SEARCH