Head Of 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:

The Head of Regulatory is responsible for the regulatory leadership of Calico's portfolio of programs to develop new therapies for aging and age-related diseases. Due to Calico's unique approach to drug development, we are seeking an individual who is excited by and has the expertise to provide strategic regulatory support for a wide diversity of drug targets and indications. She/he will continuously evaluate the regulatory landscape, develop regulatory strategy for individual projects and the portfolio as a whole, to ensure that Calico development programs will meet the requirements of global health authorities at each stage of development. The Head of Regulatory will develop along with our alliance partners regulatory strategy and represent Calico regulatory affairs in cross-functional teams. A long-term goal is for the Head to work with global regulatory authorities to develop far-sighted policies and guidance needed for the industry to meet the unique challenges of developing therapies related to aging and

extending the human health-span.

• Lead Calico's regulatory strategies and serve as the primary point of contact to our development partner(s), coordinating communication strategies with our alliance partners and the US Food and Drug Administration (FDA) and other global regulatory authorities (GRA)

• Work proactively with relevant scientific leaders and FDA/GRA to develop far-sighted policies and guidance for Calico and the rest of the industry to use to create the therapies of the future for the unique and challenging indications related to aging and extending the human health-span

• Provide regulatory leadership, feedback, and support to cross-functional teams internal to Calico and with partners

• Proactively work with Calico's partners' regulatory teams who prepare the investigational new drug applications (IND), ex-US clinical trial applications (CTA), new drug applications (NDA), and related correspondence with FDA/GRA

• Partner with external vendors in support of regulatory document preparation and

submission, if necessary

• Maintain up-to-date knowledge of the regulatory landscape, regulations, and guidelines; provides guidance and education to Calico personnel on regulatory matters, as necessary

• Leads teams to develop, implement, and deliver the regulatory strategy for development programs

• Identify regulatory risk and mitigation plans

Position Requirements:

• Bachelor's degree in a scientific discipline required. Advanced degree in life sciences and research and/or development experience strongly preferred

• Experience with regulatory requirements and strategy for small molecule development

• 10 years' experience in regulatory affairs or equivalent in a relevant field

• Broad understanding of international regulations and guidance

• Strong experience in IND and CTA filings. NDA/BLA/MAA filing experience strongly preferred

• Excellent written and verbal communication skills

• Exceptional influencing, partnership, and collaboration skills

• Strong ability to prioritize workload and work independently

• Well-prepared, competent, and confident when interacting with senior management, health authorities, and internal and external partners

• Able to prospectively identify potential problems and to partner effectively and positively to solve issues

• Must be willing to work onsite at least three days per week

The estimated base salary range for this role is $283,000 - $357,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.