As a joint venture between MD Anderson Cancer Center and Berkeley Lights, Optera Therapeutics is a new clinical-stage biopharmaceutical company offering a unique and synergistic combination of biology and technology to develop best in class cell therapies for patients suffering from diseases with grave unmet needs. Optera is currently developing two first-in-class, clinical-stage cell therapy programs and has exclusive rights to future cell therapy programs innovated at MD Anderson.
Based in San Diego, CA, Optera is currently seeking an exceptional Regulatory leader to join our team. Expanding on his/her previous successful track record in cell therapy, biologics and/or first-in-class programs developed for high unmet indications with no approved therapies or regulatory precedent, the VP, Regulatory will serve as global regulatory lead with responsibility for regulatory strategies and submissions for Optera’s Development Programs.
This is an exceptional opportunity to build, lead and develop a successful Regulatory function in a dynamic start-up company driven by a leadership team of proven drug developers.
Serve as global regulatory lead with responsibility for regulatory strategies and submissions
Provide regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development.
Ensure high‑quality and timely regulatory submissions (IND and BLA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals.
Seek preferred regulatory designations such as RMAT/BTD, PRIME, Sakigake, as applicable.
Act as the primary liaison between Optera and regulatory authorities.
Build partnerships with cross-functional key stakeholders ensure that strategic business goals are met through the sharing of knowledge and expertise.
Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape.
Build out team/department in lean, cost-efficient manner, on an as needed basis.
Support team in diligence of additional assets and in licensing discussions with potential pharmaceutical partners.
A minimum of a Bachelor’s degree in life sciences, with an advanced technical degree of an MSc or PhD highly preferred, with at least 10 years industry experience.
Strong Regulatory experience both in clinical and CMC registration-enabling strategies.
Experience in cell therapy, biologics.
Experience in orphan disease and orphan drug applications.
Successful submission, approval, and post-approval management of a BLA preferred.
Experience with preferred regulatory designations such as RMAT/BTD, PRIME, Sakigake highly desirable.
Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence management skills.
Experience in building out a comprehensive regulatory affairs function.
Ability to think strategically while maintaining a hands-on tactical approach.
Willingness to drive product submissions, including document-writing in a lean, small company environment will be a critical success factor.
Interested candidates, please submit resumes to firstname.lastname@example.org