Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program is entering into a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. Click has expanded their pipeline to include a focus on developing treatments for Serious Mental Illness (SMI) and additional major pipeline expansion and progression is in process.
About the Role
The Manager, Regulatory Affairs drives the execution of regulatory initiatives for multiple Software as a Medical Device (SaMD) products at various stages in lifecycle management. This role will support the strategy, preparation, review and submission of documents to the FDA and other global regulatory authorities for product marketing authorization. The Manager must be able to collaborate with stakeholders from scientific, quality, product, and business teams to assure that our products are developed and distributed according to all applicable regulations for SaMD in alignment with the company’s strategic goals. In meetings with the FDA and other regulators, as well as when working with development partners, the Manager will represent Click Therapeutics regulatory team.
This is a highly visible, creative, and agile role within a rapidly growing pre-IPO company in a nascent and fast-growing space. The role will be located in our TriBeCa HQ, includes great benefits, and is an excellent wealth-building/equity opportunity for the right individual.
Assist in the development of domestic and international regulatory strategies for products in Click’s pipeline.
Drive the organization and preparation of high quality pre- and post- market regulatory submissions by coordinating and collaborating with stakeholders from multiple functional areas.
Support external meetings on regulatory matters, including with regulators and auditors, development partners, and scientific and clinical advisors.
Maintain records of correspondence with regulatory agencies.
Develop and implement policies, processes, and SOPs in support of the regulatory affairs function.
Participate in strategic product development meetings, providing regulatory direction, strategies and timelines.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop strategies for resolution.
Manage processes involved with maintaining annual licenses, registrations, and listings.
Perform regulatory intelligence including monitoring changing global regulatory requirements. Assist in reviewing, assessing impact, and informing management.
Stock options | Competitive salary with annual review | 401(k) matching | Annual performance-based cash bonus | Comprehensive medical benefits through Aetna | Flexible Spending Accounts | Life insurance and disability benefits | Open vacation policy / unlimited PTO | Generous paid parental leave | Commuter subsidies | Monthly catered lunches | Choice of Mac, Windows, or Linux equipment | Sponsored company events | Free, unlimited office snacks and beverages | Much more…
Equal Employment Opportunity
Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics.
Bachelor's Degree required, preferred in life sciences, health care, or related discipline.
4-6 years of experience in an FDA regulated industry; medical device experience preferred.
3+ years of regulatory affairs experience.
A strong understanding of medical device standards and regulations (e.g., 21 CFR, MDD/MDR).
Familiarity with the legal basis of FDA’s regulatory authority, including the US Food, Drug & Cosmetic Act and related amendments.
Proven ability to prioritize, conduct, and manage time to meet project deadlines while working in a dynamic cross-functional team environment.
Experience preparing high quality regulatory submissions and/or interacting with regulatory agencies.
Excellent writing and oral communication skills with a high attention to detail.
Ability to form and maintain working professional relationships with external stakeholders, regulatory authorities, and scientific and clinical advisors.
Certification in regulatory affairs (such as RAC from the Regulatory Affairs Professionals Society)
Experience with digital therapeutics
Experience with regulatory matters concerning Software as a Medical Device (SaMD), such as artificial intelligence and machine learning
Experience with drug-device combination products and drug regulatory filings
We are a rapidly growing pre-IPO company in a nascent and fast-growing space. Our diverse, cross-functional team of experts works closely together to develop cutting-edge products where the code is the treatment. We are based in our Tribeca HQ in New York City and are committed to improving healthcare by bringing novel, safe, effective and engaging therapies to patients in need of new treatment options.