Job details

Regulatory Affairs Manager

Who We Are:

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn.

About the Role:

The Regulatory Affairs Manager 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 preparation, review and submission of documents to the FDA and other global regulatory authorities leading up to marketing authorization. The Regulatory Affairs Manager collaborates with stakeholders from medical, commercial, quality, product, and program teams to assure that our products are presented to regulatory authorities according to all applicable regulations for SaMD in alignment with the company's strategic goals. In advance of meetings with the FDA and other regulators, the Regulatory Affairs Manager prepares cross-functional team members to enable productive interactions with the Agency and attends the meetings as a representative of the Click Therapeutics regulatory team.

This position is based out of Click’s headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities or at one of our industrious offices in Boston, MA or Miami, FL. We have a hybrid working model that consists of at least 3 days in office each week.

Responsibilities:

Manage the drafting of high-quality regulatory submissions by preparing the core elements as an individual contributor and coordinating collaborative input from cross-functional stakeholders. Prepare and process the drafted documents, and submit the finalized version to the regulatory authorities.
Conduct regulatory research and provide intelligence to inform discussions with Click leadership.Coordinate regulatory strategy discussions as requested. Synthesize inputs from the team to author regulatory strategy documents based on direction set by regulatory and medical leadership.
Perform regulatory intelligence including monitoring changing global regulatory requirements. Assist in reviewing, assessing impact, and informing management.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle. Act as a resource on the cross-functional team to answer regulatory-related questions and provide regulatory direction when developing strategies for resolution.
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.
Manage processes involved with maintaining annual licenses, registrations, and listings.

Qualifications:

Bachelor's Degree required, preferred in life sciences, health care, or related discipline.
5-8 years of experience in an FDA regulated industry; medical device experience required.
3+ years of regulatory affairs experience.
A strong understanding of medical device standards and regulations (e.g., 21 CFR, FDA Guidance).
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 (e.g., regulatory authorities, scientific and clinical advisors).

Preferred Qualifications:

Experience with the Q-Submission program and/or leading FDA meetings.
Certification in regulatory affairs (such as RAC from the Regulatory Affairs Professionals Society).
Experience with digital therapeutics and/or Software as a Medical Device (SaMD) regulatory matters.
Experience working with clinical trial design, terminology, and statistical concepts.
Familiarity with the legal basis of FDA’s regulatory authority, including the US Food, Drug & Cosmetic Act and related amendments.

Compensation:

The base salary range for this position is between: $130,000 - $155,000. The final base salary will be dependent upon skills, experience and location. In addition to the base salary, Click Therapeutics offers an annual performance-based cash bonus and a generous equity package.

Benefits:

The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space.

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.

Recruitment Phishing Scams:

As recruitment phishing scams are growing, we urge you to be vigilant during the job search process. Please be mindful of the following:

Click Therapeutics will only reach out to you through an “@clicktherapeutics.com” email address.
Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver’s License Number) via email or a messaging application (like that used on the LinkedIn platform).
Click Therapeutics will conduct interviews face-to-face over Zoom.
All job postings will be listed on the Click Therapeutics official career page. If someone contacts you about a job or position that is not listed on the official career page, please contact the Click Therapeutics recruitment team at the contact information below.
If you have any questions regarding the validity of a recruitment inquiry or an interview, please contact the Click’s recruitment team at recruitment@clicktherapeutics.com to confirm before proceeding.

If you encounter a scam, report it to the Federal Trade Commission at https://reportfraud.ftc.gov/#/

Click Therapeutics Glassdoor Company Review

3.9