Cmc Program Manager Jobs in Denver, CO (NOW HIRING)

POSITION SUMMARY

The Senior Director, Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible for content development, compilation, maintenance, and review of the Nonclinical and Clinical Modules for regulatory submissions to support Umoja's drug products including, DMF, IND and NDA/BLA applications, Health Authority (HA) responses, and briefing packages (including participating in/leading HA meetings). In this role, the Senior Director will be the Regulatory Affairs leader on program teams and will provide expertise to support the development of our in vivo CAR-T therapy programs. This individual will play a critical role in regulatory strategy, study design, execution, and in leading regulatory interactions.

The ideal candidate will bring deep experience in cell & gene therapy and a strong track record in oncology or rheumatology drug development.

This role will develop and implement regulatory strategies leading to successful registration and life-cycle management of unique and technologically complex products serving patients with cancer and other unmet medical needs. It builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities.

We will consider candidates at either the Senior Director or Executive Director level based on candidate's qualifications and experience.

CORE ACCOUNTABILITIES 

Specific responsibilities include:  

• Independently provide regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs.
• Develop and execute global regulatory strategies to support indication selection, trial design, and endpoints, to support program advancement.
• Develop registration strategies and plans (e.g., TPP development and assessment) to achieve regulatory approvals and desired product labeling.
• Lead global regulatory filings (IND/CTA/BLA/MAA submissions), setting strategy for submissions of product registration documents for health authorities worldwide.
• Primary point of contact with global regulatory agencies to support program advancement.
• Effectively communicate the regulatory strategy, 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 complex issues.
• Provide 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 align overall strategy with scientific discoveries. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams.
• Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology and/or autoimmune therapeutic areas. Conduct regulatory research to assess the impact of relevant global regulations, guidance, and current regulatory environment. Provide 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.
• Provide organizational support and mentoring as company grows its product development pipeline.

The successful candidate will have:

• Senior Director Level: PhD/MS/BS in a relevant scientific field required with a minimum of 12/15/15+ years, respectively, of relevant experience in regulatory affairs. Experience in Oncology, Hematology, or related specialty strongly preferred. Successful track record of regulatory submissions and approvals.
• Executive Director Level: PhD/MS/BS in a relevant scientific field required with a minimum of 15/18/18+ years, respectively, of relevant experience in regulatory affairs. Experience in Oncology, Hematology, or related specialty strongly preferred. Successful track record of regulatory submissions and approvals.
• Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities preferred; experience in in vivo gene delivery a plus.
• Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies.
• Proven ability to interact with regulatory authorities.
• Excellent communication, leadership, and cross-functional collaboration skills.
• Passion for innovation and commitment to advancing transformative therapies for patients.

Physical Requirements:  

• Ability to travel (~20%) for team meetings and/or regulatory interactions as required. Some international travel possible.
• Ability to sit for prolonged periods of time

Senior Director Salary Range: $253,000 - $312,500
Executive Director Salary Range: $272,900 - $337,000