Menlo Ventures
Associate Director of Regulatory Affairs
Menlo Ventures, Salt Lake City, Utah, United States, 84193
Your work will change lives. Including your own.
The Impact You’ll MakeRecursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data, and superlinearly scaling our efforts to accelerate the delivery of high-potential drug candidates to the clinic. We are seeking an Associate Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks for the assigned programs. Collaborate with cross-functional leads to support the development of regulatory strategies and implementation for all jurisdictions as applicable to the program. Plan and perform critical reviews of documents for consistency and quality, and identify gaps in critical documentation in alignment with the regulatory strategy with the intention of achieving successful registration and lifecycle management of unique products.Working Location:Making Salt Lake City your home base is ideal, however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.The Team You’ll JoinReporting to the Vice President, Regulatory, you’ll lead the development of regulatory strategies for the assigned program within the Regulatory Department. As the regulatory operations and publishing representative on this diverse team, you’ll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs (IND-enabling and clinical-stage assets) in alignment with Recursion’s regulatory strategy.In this role, you will:Build
intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization to ensure management of regulatory strategy and activities in all applicable regulatory jurisdictions (e.g. EU, US, UK) for the global development of products through all stages of development and post-approval. Participate in global product team meetings; provide regulatory support and guidance and manage day-to-day regulatory activities.Manage
complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion while practicing sound judgment as it relates to risk assessment (immediate and long-term impact on program).Create
and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, pediatric submissions, etc.). Create, collaborate and comply with disclosure and transparency policies for applicable jurisdictions.Collaborate
with strategic operations and other functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight for futuristic planning and considerations for the program.Serve , as needed, as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.Review
and interpret regulatory guidelines and create a communication plan to distribute relevant impact assessment. Creatively think outside the box on how to influence and shape the future of regulatory sciences as it relates to use and validation of unprecedented use of technology to develop drugs effectively for faster paths to patients.Learn : Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. Represent regulatory function and demonstrate respectful behavior, leadership, ethics, and transparency.The Experience You’ll NeedA minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs, experience with major Health Authority (US FDA, Health Canada, UK MHRA and EMA) is mandatory.Minimum of 6 years experience with regulatory submissions (e.g. Investigational New Drug Applications(INDs), New Drug Applications (NDA/NDS/MAA), post-marketing measures, Paediatric Investigation Plans (PIP)/(PSP) and Orphan Drug Designation (ODD), Breakthrough Designation (BTD), EU PRIME activities) are mandatory.Strong understanding of regulatory strategy and implementation of operational activities. Outstanding management, interpersonal, communication, negotiation, and problem-solving skills. Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams.How You’ll be SupportedAt Recursion, we’re working to solve some of the most meaningful challenges in human health. During onboarding, you’ll be introduced to the Recursion Mindset and Recursion OS through a blend of in-person and online resources designed to help you quickly embrace our culture. You’ll be paired with an onboarding "Trail Guide" to support you in your first months and connect with colleagues, both in person and remotely, who will guide you through the traditional and Recursion-specific aspects of your role. Additionally, you’ll join onboarding events, like Decoding Recursion, to deepen your understanding and integration into the team.At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is:Developing: $152,000Skilled: $168,000Expert: $186,000To learn more about our level within levels, click
here .You will also be eligible for bonuses and equity compensation + our comprehensive benefits package for United States based candidates. The range displayed on each job posting reflects target ranges for US new hire salaries and is determined by job, level, and market factors.During the interview selection process, you will connect with a Talent Acquisition Partner who will be your advocate and ally to ensure you receive the appropriate compensation that meets your needs for your skills, experience, and relevant education/training, while also reviewing our very competitive total rewards package.#LI-CP1The Values That We Hope You Share:We Care:
We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.We Learn:
Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.We Deliver:
We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover.Act Boldly with Integrity:
No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.We are One Recursion:
We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.Recursion spends time and energy connecting every aspect of work to these values. They aren’t static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work.More About RecursionRecursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.Recursion is headquartered in Salt Lake City, where it is a founding member of
BioHive , the Utah life sciences industry collective. Recursion also has offices in London, Toronto, Montreal and the San Francisco Bay Area. Learn more at
www.Recursion.com , or connect on
X
(formerly Twitter) and
LinkedIn .Recursion is an Equal Opportunity Employer that values diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Recursion welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.#J-18808-Ljbffr
The Impact You’ll MakeRecursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data, and superlinearly scaling our efforts to accelerate the delivery of high-potential drug candidates to the clinic. We are seeking an Associate Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks for the assigned programs. Collaborate with cross-functional leads to support the development of regulatory strategies and implementation for all jurisdictions as applicable to the program. Plan and perform critical reviews of documents for consistency and quality, and identify gaps in critical documentation in alignment with the regulatory strategy with the intention of achieving successful registration and lifecycle management of unique products.Working Location:Making Salt Lake City your home base is ideal, however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.The Team You’ll JoinReporting to the Vice President, Regulatory, you’ll lead the development of regulatory strategies for the assigned program within the Regulatory Department. As the regulatory operations and publishing representative on this diverse team, you’ll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs (IND-enabling and clinical-stage assets) in alignment with Recursion’s regulatory strategy.In this role, you will:Build
intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization to ensure management of regulatory strategy and activities in all applicable regulatory jurisdictions (e.g. EU, US, UK) for the global development of products through all stages of development and post-approval. Participate in global product team meetings; provide regulatory support and guidance and manage day-to-day regulatory activities.Manage
complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion while practicing sound judgment as it relates to risk assessment (immediate and long-term impact on program).Create
and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, pediatric submissions, etc.). Create, collaborate and comply with disclosure and transparency policies for applicable jurisdictions.Collaborate
with strategic operations and other functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight for futuristic planning and considerations for the program.Serve , as needed, as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.Review
and interpret regulatory guidelines and create a communication plan to distribute relevant impact assessment. Creatively think outside the box on how to influence and shape the future of regulatory sciences as it relates to use and validation of unprecedented use of technology to develop drugs effectively for faster paths to patients.Learn : Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. Represent regulatory function and demonstrate respectful behavior, leadership, ethics, and transparency.The Experience You’ll NeedA minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs, experience with major Health Authority (US FDA, Health Canada, UK MHRA and EMA) is mandatory.Minimum of 6 years experience with regulatory submissions (e.g. Investigational New Drug Applications(INDs), New Drug Applications (NDA/NDS/MAA), post-marketing measures, Paediatric Investigation Plans (PIP)/(PSP) and Orphan Drug Designation (ODD), Breakthrough Designation (BTD), EU PRIME activities) are mandatory.Strong understanding of regulatory strategy and implementation of operational activities. Outstanding management, interpersonal, communication, negotiation, and problem-solving skills. Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams.How You’ll be SupportedAt Recursion, we’re working to solve some of the most meaningful challenges in human health. During onboarding, you’ll be introduced to the Recursion Mindset and Recursion OS through a blend of in-person and online resources designed to help you quickly embrace our culture. You’ll be paired with an onboarding "Trail Guide" to support you in your first months and connect with colleagues, both in person and remotely, who will guide you through the traditional and Recursion-specific aspects of your role. Additionally, you’ll join onboarding events, like Decoding Recursion, to deepen your understanding and integration into the team.At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is:Developing: $152,000Skilled: $168,000Expert: $186,000To learn more about our level within levels, click
here .You will also be eligible for bonuses and equity compensation + our comprehensive benefits package for United States based candidates. The range displayed on each job posting reflects target ranges for US new hire salaries and is determined by job, level, and market factors.During the interview selection process, you will connect with a Talent Acquisition Partner who will be your advocate and ally to ensure you receive the appropriate compensation that meets your needs for your skills, experience, and relevant education/training, while also reviewing our very competitive total rewards package.#LI-CP1The Values That We Hope You Share:We Care:
We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.We Learn:
Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.We Deliver:
We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover.Act Boldly with Integrity:
No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.We are One Recursion:
We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.Recursion spends time and energy connecting every aspect of work to these values. They aren’t static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work.More About RecursionRecursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.Recursion is headquartered in Salt Lake City, where it is a founding member of
BioHive , the Utah life sciences industry collective. Recursion also has offices in London, Toronto, Montreal and the San Francisco Bay Area. Learn more at
www.Recursion.com , or connect on
X
(formerly Twitter) and
LinkedIn .Recursion is an Equal Opportunity Employer that values diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Recursion welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.#J-18808-Ljbffr