This late-stage biotechnology company is developing first-in class T Cell based cancer immunotherapies. They are seeking a Regulatory CMC Manager or Senior Manager who can contribute to the development and execution of CMC Regulatory strategies for their clinical and commercial products. With their lead candidate in Phase 3, this company offers innovative science, competitive compensation and a patient-focused company culture. This role is fully remote with some occasional travel. Now is an exciting time to join this innovative organization and improve the lives of patients in need!
Responsibilities:
- Work with cross-functional project teams to develop CMC regulatory strategies for cell therapy programs at all stages of development.
- Represent Regulatory CMC on cross-functional teams and work closely with team members to support corporate objectives.
- Interface with Quality Assurance, clinical manufacturing, commercial manufacturing and other stakeholders to further develop and maintain a robust change control program.
- Work within the CMC Regulatory Affairs team to gain consensus on proposed changes.
- Negotiate with internal stakeholders to ensure that proposed changes and submission content are aligned with ICH guidelines, country regulations and guidelines, and industry standards.
- Represent Regulatory Affairs at change control meetings and other meetings involving life cycle management as the CMC RA expert.
- Participate in risk mitigation by proactively identifying risk, developing options and contingency plans.
- Help maintain submission files and logs.
Required Qualifications:
- BS degree in Biochemistry, Biology, Chemistry, Engineering or related field required; advanced degree preferred.
- Minimum 5+ years in CMC Regulatory for biologic product. Cell therapy experience a plus.
- Ability to develop and lead CMC life cycle management efforts with an emphasis on change control systems.
- Investigational and Commercial Regulatory CMC experience preferred.
- Strong US regulatory background. Ex-US experience a plus.
- Able to lead the planning and writing of CMC documents that will meet authority expectations.
- Excellent written skills and the ability to form defensible arguments based on data, literature references, industry standards, and country regulations/guidelines.
- Excellent organizational and planning skills.
- Ability to build positive relationships with co-workers of various backgrounds and expertise.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
- Must be comfortable with ambiguity within an evolving company.