Gamida Cell is an advanced cell therapy company committed to finding cures for cancer and other serious diseases. We apply a proprietary expansion platform to allogeneic cell sources, including umbilical cord blood-derived cells and NK cells, which leverages the properties of nicotinamide (NAM) to create products with the potential to redefine standards of care.
Omidubicel, Gamida Cell’s lead investigational product candidate, is under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies, and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Omidubicel met all of its primary and secondary endpoints in a Phase 3 study. Gamida Cell plans to submit a BLA for omidubicel by the end of 2021 with an anticipated product approval and launch in mid-2022. Gamida Cell is also pioneering modified and unmodified NAM-enabled NK cell therapies targeted at solid tumor and hematological malignancies.
Gamida Cell is a global, publicly traded biotechnology company (Nasdaq: GMDA) with locations in Israel and the United States. Additional information can be found on our website at www.gamida-cell.com.
General Scope and Summary
Reporting to the Chief RA and QA Officer, the Director, Regulatory Advertising, Promotion and Labeling will be responsible for providing strategic and tactical regulatory support on the development and implementation of advertising and promotional materials for our lead asset, omidubicel, as well as future pipeline assets. This position will work cross functionally to ensure that product materials are following business objectives and follow regulatory requirements, both in the U.S. with the FDA as well as global regulatory bodies.
Roles and Responsibilities
- Provide commercial regulatory knowledge, guidance and recommendations relating to product promotion materials that align with the overall strategy of Gamida Cell’s drug candidates.
- Serve as a regulatory leader while working cross functionally to create and review materials for our lead asset, omidubicel, to ensure compliance with corporate and regulatory requirements.
- Remain current on FDA regulations and guidance associated with advertising, promotion and labeling.
- Ensure promotional activities support business needs while appropriately mitigating promotional risks.
- Develop and maintain relationships with the FDA and other global regulatory agencies on advertising and promotional labeling-related activities; stay current on latest trends, regulations, and market dynamics/information.
- Partner with commercial, medical and scientific colleagues on the development of materials related to advertising and promotion.
- Provide training on advertising and promotion regulations to key stakeholders.
Experience, Education and Specialized Knowledge and Skills
- B.S. degree with relevant/scientific experience; advanced degree preferred in related field.
- 10+ years of experience involving regulatory affairs; specifically, the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical industry.
- Strong knowledge of regulatory requirements for compliant advertising and promotional materials.
- The ability to comprehend and analyze complex trends; translate trends into actionable plans.
- Ability to influence others and communicate difficult concepts in a manner which aligns cross functional team members.
- Ability to build effective cross functional relationships while providing creative solutions; ability to act in a collaborative manner that helps teams make decisions within regulatory frameworks.
- Experience on working on multiple product approvals, both within the U.S. as well as globally.
- Strong organization skills and attention to detail; ability to manage multiple priorities and ongoing projects simultaneously.
- Excellent interpersonal and communication (both written and verbal) skills.
Travel: 10%, once travel resumes
Reports to: Chief RA and QA Officer
To apply: Send resume and cover letter to email@example.com.