What are the responsibilities and job description for the Associate Director, Regulatory Project Management position at Cartesian Therapeutics?
Cartesian Therapeutics, Inc. is reimagining cell therapies with transformative technologies to bring a new generation of treatment options to patients with autoimmune diseases. We are seeking an experienced regulatory professional to join Cartesian as an Associate Director, Regulatory Project Management. The Associate Director, Regulatory Project Management will manage Cartesian's regulatory portfolio of US and ex-US filings, supporting both the clinical and CMC regulatory leaders.
Key Responsibilities :
- Project management support to both clinical and CMC regulatory efforts
- Develop and manage submission content plans, including timelines and resources, ensuring projects are completed on time.
- Manage regulatory relationships with key partners and vendors, as needed.
- Collaborate with clinical and CMC regulatory leaders to author regulatory documents.
- Monitor and track deliverable progress, identify potential risks, and develop and implement mitigation strategies.
- Conduct regular project meetings and provide updates on status, issues, and changes to senior leadership and stakeholders.
- Ensure that regulatory reporting and documentation requirements are met.
- Manage responses to Health Authority inquiries, track commitments to Health Authorities, and convene internal and external resources as needed to address Heath Authority queries.
Qualifications :
Desired Key Competencies :
Salary Notice :
At Cartesian Therapeutics, we are committed to transparency and equity in our compensation practices. The salary range for this position is $150,000 to $180,000 per year. Please note that the final salary will be determined based on several factors, including but not limited to years of experience, industry experience, education, and specific skills relevant to the role. We believe in rewarding our team members fairly and encourage open discussions about compensation throughout the hiring process.
Cartesian is an Equal Opportunity Employer and is committed to fostering an environment in which all employees are treated fairly without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, ancestry, disability, marital status, genetic information, military status, or any other characteristic protected under applicable law.
Salary : $150,000 - $180,000
