Reporting to the Vice President of Regulatory Affairs, the Regulatory Affairs Manager will assist with and manage regulatory submissions and help develop strategies that are in accordance with therapeutic area direction and corporate objectives. Primary responsibilities include preparing regulatory documents, serving as a regulatory contact on assigned clinical trials, developing processes and timelines in support of designated regulatory activities, and tracking submissions.
Participate in cross functional project teams to deliver successful submissions/filings and outcomes with Health Authorities (HA) for therapeutic programs
Serve as a regulatory contact for designated trials: assist with developing timelines, preparing and maintaining clinical trial applications, track status of submissions, and Health Authority commitments. Coordinate with CROs or vendors on clinical trial activities in support of regulatory goals
Collaborate with team members to draft responses to health authority requests
Ensure consistency, completeness, accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions
Contribute to the regulatory strategy, including identifying and communicating potential risks and mitigation plans associated with regulatory strategies
Contribute to interactions with Health Authorities including assisting in developing briefing packages and prep meetings
Prepare regulatory operations Standard Operating Procedures (SOPs); provide regulatory review of SOPs from other departments as necessary?
Ability to travel domestically and internationally as needed
This position is eligible to work from home, with occasional travel to the office required, work from the office, or a combination of working from home and the office.
Direct experience in preparing registration (IND, NDA, CTA, and/or NDS) submissions required
Strong knowledge of FDA guidelines for the development of small molecule products is preferred
Experience working with Health Canada and filing CTA and NDS submissions is preferred
Strong project management and organizational skills with emphasis on attention to detail
Excellent interpersonal and verbal/written communication skills with the ability to build relationships at all levels of the organization
Ability to work independently on multiple projects with tight timelines and minimal supervision
Experience working with CROs on regulatory submissions in support of clinical trials
Proficient at using MS Office products
Experience with cloud-based document management programs and/or document management systems and co-authoring tools is preferred
Regulatory Affairs Certification or similar certificate is a plus
Education and Experience
BA/BS degree, preferably in the life sciences, and a minimum of 5 years regulatory experience is required, or an equivalent combination of experience and education
This is a remote/office hybrid boulder, CO based position, with occasional travel both domestically and internationally required
Brickell Biotech, Inc. is a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of dermatologic, autoimmune and other debilitating diseases. Brickell’s pipeline combines a potential best-in-class, late clinical-stage program for hyperhidrosis with a novel, cutting-edge platform with broad potential in autoimmune and neuroinflammatory disorders.
Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®.
Brickell’s strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative products that Brickell believes can meaningfully benefit patients who are suffering from debilitating diseases that are underserved by available therapies.