Director, Regulatory Affairs

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description :

Calico is seeking a Regulatory Director that will be responsible for, in collaboration with development partners as applicable, developing and implementing innovative regulatory strategies to support development programs, in compliance with health authority guidelines and regulations. The successful candidate should be able to collaborate effectively with cross-functional representatives, collaboration partners, external vendors, and stakeholders, while maintaining a positive team environment.

Position Responsibilities:

Accountable to develop and execute the world-wide regulatory strategy for assigned programs (from IND-enabling to clinical proof-of-concept and beyond), which may include programs that are first-in-class, where no or limited FDA guidance exists, that have an external business partner, and where there are multiple indications

Provide high-level regulatory counsel to Executive Leadership, Clinical Development, CMC, and Commercial teams regarding clinical trial designs, surrogate endpoints, accelerated approval strategies, and risk mitigation

Lead interactions with global health agencies to inform global regulatory/ registration requirements for assigned programs, developing briefing packages for such engagements

Collaborate with the executive team to define regulatory strategies consistent with Calico’s mission for both internal and partnership programs

Oversee or directly enable the compilation, review, and submission of regulatory applications and submissions to agencies, ensuring accuracy, completeness, and timeliness

Collaborate with CMC, CMC Regulatory, and other stakeholders to develop effective CMC regulatory strategies

Represent Regulatory Affairs on development teams and support development teams in interpreting and applying regulations and guidance documents

Offer strategic and regulatory compliance input to protocols, reports, and other source documents

Stay updated on global regulatory guidance and regulations, communicating key updates to senior leadership and project teams, anticipating changes in the regulatory landscape, and developing proactive strategies accordingly

Collaborate with cross-functional teams and support functions, including full-time staff and independent consultants, as required

Other duties as assigned

Position Requirements:

Master’s degree in a life science discipline from an accredited college or university; PhD preferred

Minimum of 10 years of regulatory affairs experience in an industry, academia, or clinical research organization setting, with experience with rare disease development and/or novel endpoints preferred

Proven track record of developing and executing regulatory submissions in the biotechnology sector, including experience with at least one major application and approval, preferred (NDA, BLA, MAA, etc.)

Direct experience authoring and managing (or oversight of others) substantial regulatory submissions (INDs/CTAs required; experience with successful NDA/BLA/MAA filings is highly desirable)

Strong knowledge of global regulations, including, but not limited to, FDA and EMA

Experience with mechanisms to expedite agency interactions

Advanced skill in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development, and in leading productive health authority interactions, including well organized preparation of cross functional teams

Excellent communication skills with the ability to influence stakeholders internally and externally

Self-motivated, with the ability to work independently or as part of a team

Strategic thinker with strong problem-solving skills

Exceptional organizational skills with the ability to prioritize tasks in a fast-paced environment

Self-motivated and able to work collaboratively

Ability to “roll up sleeves” in a start-up environment and a positive can-do attitude

Must be willing to work onsite at least four days per week

The estimated base salary range for this role is $275,000 - $280,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.