Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).
Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive topline data from the study were reported in May 2020.
General Scope and Summary
Gamida Cell is looking for a Regulatory Affairs leader to join the team for directing innovative global regulatory strategies for product development and approval. Responsible for defining strategies for meeting and keeping post approval compliance. Responsible for regulatory documents, submissions, and compliance issues. Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. Provide mentorship and leadership to others, both direct reports as well as cross-functionally.
Roles and Responsibilities
- Effectively establish, resource and manage the company’s regulatory affairs function in USA, providing strong leadership and focus.
- Develop and implement appropriate regulatory labelling strategies to support marketing applications for U.S., EU and other RoW territories of the company’s development candidates.
- Ensure that the company’s products are developed to be regionally compliant and that they remain in regulatory compliance; define strategies to mitigate risks.
- Keep abreast of new FDA regulatory requirements (as well as those from other key international regulatory authorities) and anticipate their future impact on Gamida Cell.
- Develop and maintain strong relationships with health authorities/regulators, contractors and corporate partners while negotiating on behalf of Gamida Cell.
- Promote a positive work environment by communicating a clear direction on goals, provide support to other areas, and work in a fashion consistent with Gamida Cells’ values.
- Play a substantive role in the preparation of submission-relevant documents relating to Gamida’s development activities, including BLA and MAA submissions, label extensions, post-approval regulatory obligations, etc.
- Play a key role in providing guidance and advice to product development project teams with respect to regulatory requirements and trends affecting corporate strategy, programs, business development and processes.
- Assess compliance of CMC documents with current guidelines and regulations. Recommend strategies to achieve such compliance; assess impact of proposed CMC changes to licenses or clinical trial applications.
- Oversee regulatory promotional compliance.
- Provide input to Executive Management team(s).
- Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
Experience, Education and Specialized Knowledge and Skills
- BS degree in sciences, preferably life sciences.
- 8 years pharmaceutical/biotechnology industry experience with technical management experience.
- Minimum of 6 years in RA, with in-depth knowledge of applicable regulations.
- Experience in interpretation of regulations, guidelines, policy statements, etc.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Experience in interfacing with relevant regulatory authorities.
- Foster effective, positive interactions with regulatory agencies, and corporate partners.
- Ability to lead, influence and represent project teams, committees, external meeting etc. to attain group goals.
- Demonstrate excellent leadership, organization and communication skills.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
- Strong sensitivity for a multicultural/multinational environment.
- Ability to guide, train, mentor, supervise and prioritize workload of direct reports.
Travel: 20%, once travel resumes
Reports to: Chief Regulatory Affairs and Quality Assurance Office
To apply: Send resume and cover letter to email@example.com.