Senior Manager, Regulatory Affairs
United States /
Regulatory /
Remote
/ Remote
Cullinan Oncology is dedicated to creating new standards of care for patients with cancer.
We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners.
Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications.
Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization.
As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.
Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer.
Summary:
The Senior Manager, Regulatory Affairs, will be responsible for planning, coordinating, and managing the completion of regulatory documents for submission to health authorities and provide regulatory strategy and guidance necessary to support cross-functional project development teams.
Position Responsibilities:
- With minimal supervision, plan and manage regulatory activities related to assigned projects that encompass technical areas including clinical, non-clinical, and CMC.
- Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
- Prepare and maintain regulatory archive
- Leads regulatory communications and interactions with health authorities
- Serve as the Regulatory Lead for one or more programs and contributes to or may lead the development and implementation of regulatory strategies for development programs
- Provide regulatory guidance and support to cross-functional teams, including performing risk assessments and managing critical issues
- Develop and maintain current regulatory knowledge and advise management of significant developments
- Work with external regulatory consultants/CRO’s as required
Candidate Requirements:
- Comprehensive understanding of the drug development process, pharmaceutical industry regulatory requirements, healthcare environment and policy
- Experience with INDs/CTAs, product development, development of regulatory strategies
- Able to assess and understand complex scientific information and regulatory guidelines and make recommendations based on assessment
- Strong problem-solving skills, detail oriented, flexible
- Strong written and verbal communication skills
- Able to effectively lead and work in a fast-paced, matrixed environment
- BA/BS degree in biological/physical sciences required. Advanced degrees preferred
- 5+ years relevant Regulatory Affairs experience in the biotechnology or pharmaceutical industry or a combination of education and experience
Cullinan Oncology is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
