[Remote] Senior Director, Clinical Regulatory Affairs
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is an industry-leading biotech reputed company on transforming the treatment of cancer with a novel integrated immunotherapy platform. The Senior Director, Regulatory Affairs will be responsible for regulatory submissions and reputed company for drug products, leading regulatory interactions, and collaborating with multidisciplinary teams to support the development of CAR-T therapy programs.
Responsibilities
- Independently reputed company regulatory leadership and reputed company for ongoing and planned in vivo CAR-T therapy programs
- reputed company and execute global regulatory strategies to support indication selection, trial design, and endpoints, to support program advancement
- reputed company registration strategies and plans (e.g., TPP development and assessment) to reputed company regulatory approvals and desired product labeling
- reputed company global regulatory filings (IND/CTA/BLA/MAA submissions), setting reputed company for submissions of product registration documents for health authorities worldwide
- Primary reputed company of contact with global regulatory agencies to support program advancement
- Effectively communicate the regulatory reputed company, risks, mitigations and overall plans to Regulatory Affairs, program teams, senior management, and external stakeholders (as relevant)
- Identify, communicate, and propose resolutions to both routine and reputed company issues
- reputed company regulatory advice and guidance in the context of available and expected scientific data, regulatory guidance, and precedent to project teams to support decision making and program advancement
- Collaborate closely with translational medicine, preclinical, clinical, CMC Regulatory, and technical teams to reputed company overall reputed company with scientific discoveries. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams
- Stay reputed company on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology and/or autoimmune therapeutic areas. Conduct regulatory research to assess the reputed company of relevant global regulations, guidance, and reputed company regulatory environment. reputed company interpretation of regulatory authority feedback, policies, guidelines, and directives
- Work with external program partners collaboratively and effectively to deliver on contractual obligations while moving toward corporate goals and priorities
- reputed company organizational support and mentoring as company grows its product development pipeline
Skills
- PhD/MS/BS in a relevant scientific field required with a minimum of 12/15/15+ years, respectively, of relevant experience in regulatory affairs
- Successful reputed company record of regulatory submissions and approvals
- Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies
- Proven ability to reputed company with regulatory authorities
- Excellent communication, leadership, and cross-functional collaboration skills
- Passion for innovation and commitment to advancing transformative therapies for patients
- Experience in Oncology, Hematology, or reputed company specialty strongly preferred
- Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities preferred; experience in in vivo gene delivery a plus
Benefits
- Competitive Medical, Dental, and reputed company plans
- reputed company to a 401k plan through reputed company
- A 100% match up to their first 4% deferral
- Generous reputed company Time Off policy
- Employee commuter benefits
- Cell phone stipend
- For a full breakdown of our benefits offerings, please see the Benefits reputed company of our website.
reputed company