Calico
Director, Regulatory Affairs
South San Francisco, CA · Director · Full-time
Sponsorship not specified$275k-$280kDetected 16 days ago
ComplianceClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingOrganizational SkillsRegulatory Affairs
About the role
- Actual pay will be based on a number of factors including experience and qualifications.
- This position is also eligible for two annual cash bonuses.
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
- Collaborate with the executive team to define regulatory strategies consistent with Calico's mission for both internal and partnership programs
- 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
- 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.
Requirements
- 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
- Excellent communication skills with the ability to influence stakeholders internally and externally
- Exceptional organizational skills with the ability to prioritize tasks in a fast-paced environment
- Ability to "roll up sleeves" in a start-up environment and a positive can-do attitude
- Collaborate with cross-functional teams and support functions, including full-time staff and independent consultants, as required
Nice to have
- Master's degree in a life science discipline from an accredited college or university
- 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.)
Compensation
- The estimated base salary range for this role is $275,000 - $280,000.
Benefits
- Lead interactions with global health agencies to inform global regulatory/ registration requirements for assigned programs, developing briefing packages for such engagements
Company info
- 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.
- 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.
- 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.
- Self-motivated, with the ability to work independently or as part of a team
This listing is sourced directly from Calico's careers page and normalized into a canonical job model.