Job Title: Manager, Regulatory Affairs
FLSA Status: Full-Time/Exempt
Department: Clinical Development
Date: June 28, 2022
Manager: Exec. Dir Clinical
Location: Pittsburgh PA or Remote
Job Code: BSB-22-031
BlueSphere Bio was founded to deploy its novel TCXpress technology to unlock the potential of personalized T cell therapy for cancer treatment by harnessing the unique specificity of each patient’s T cells for the molecular fingerprint of each patient’s cancer.
Our trailblazing, proprietary TCXpress platform is an elegant, rapid approach that exploits the patient’s immune defenses to attack their cancer specifically and is designed to leave normal tissues untouched, thereby reducing harmful side effects.
The TCXpress platform and its implementation will deliver rapid, personalized T cell treatments for various cancer indications.
We are seeking a creative, experienced Manager of Global Regulatory Affairs to help build the company’s pipeline and transform patient lives. This role will be part of the company’s development team and contribute to the company’s vision, reporting to the Executive Director of Clinical Development. The Manager of Global Regulatory Affairs will be a key position that is accountable for development and execution of worldwide regulatory strategy, including authoring of regulatory documents. The candidate is responsible for managing all interactions with and submissions to regulatory authorities. The candidate must be able to efficiently lead and interact with multi-disciplinary teams. The successful candidate will have a track record of accomplishments in global regulatory affairs, specifically cell and gene therapy products and adoptive T cell therapies. S/he must exhibit excellent leadership, project management, and strong collaboration and communication skills.
Duties and Responsibilities
- Write and edit briefing books, regulatory agency responses, and other documents for national and international studies/submissions, including product labeling.
- Work with the Head of Regulatory Affairs and project teams on the development and execution of regulatory strategy and operations throughout the development process.
- Lead interactions with FDA and other Health Authorities, including as they pertain to CMC.
- Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible.
- Manage external regulatory and cross-functional vendors and consultants to ensure successful regulatory submissions.
- Author SOPs, process documents, global policies, author guidance, and other documents to support the organization.
- Ensure documents are accurate, complete, and adhere to applicable regulatory guidelines and departmental and editorial standards, and are appropriately formatted for publishing and submission.
- Other duties as assigned
Qualifications and Work Experience
- A minimum of a Bachelor’s Degree in a related science is required, advanced degree (Masters or PhD) preferred.
- At least 5-8 years of regulatory experience in Regulatory Affairs in a pharmaceutical or biotechnology environment. Experience in cell therapy preferred.
- Excellent working knowledge of the US and European regulations regarding biologics and cell and gene therapy.
- Must have extensive knowledge of regulatory requirements and guidances, including ICH and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business.
- Experience in the preparation and submission of IND/CTAs and BLA/NDA/MAAs within expedited timelines across the ICH regions.
- Demonstrated regulatory leadership of multiple global development programs and NDA/MAA submissions.
- Negotiation, influence, and excellent interpersonal communication skills are required.
- Extensive experience with regulatory operations and submission publishing.
- Ability to thrive in a fast paced early-stage company environment that requires “hands-on” contribution, optimal use of limited resources and an ability to work closely and collaboratively with others in a small team setting.
- Must be able to travel (US/international) up to 20%.
Physical and Mental Requirements
- You will be expected to occasionally (1% to 20% of the time):
- Climb stairs, ramps, ladders. Etc.
- Stoop/crouch by bending your legs or bending down/forward at the waist
- Reach by extending the hands/arms
- Lift objects from one level to another (30 lbs. or less)
- Carry objects (30 lbs. or less)
- Travel (<5%)
- You will be expected to frequently (21% to 50% of the time):
- Walk around the facility on foot
- Stand on your feet
- You will be expected to constantly (at least 51% of the time):
- Sit in a normal seated position
BlueSphere Bio is an Equal Opportunity Employer (EOE) and offers employment opportunities to all qualified persons regardless of race, color, religion, sex, age, national origin or ancestry, physical or mental disability (except where physical or mental abilities are a bona fide occupational requirement), veteran status, marital status, familial status, sexual orientation, HIV-positive status, possession of the sickle cell trait, genetic characteristics, political views, and any other basis protected by federal, state or local laws.
Please send a cover letter to apply for this position (including job code) and a CV/Resume. Internal candidates interested in this opportunity should submit their CV/Resume within 2-weeks of the posting date above and explain why you are interested in this position.