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.
