Director, Regulatory Affairs Strategy
Aquestive Therapeutics, Trenton, NJ, United States
The Director of Regulatory Affairs is responsible for executing the company’s regulatory strategy across the development and commercial product portfolio. This role reports to the Senior Vice President, Regulatory Affairs. This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. As a leader in the organization, this role oversees the management of day-to-day operations of the regulatory affairs function. This includes management and maintenance of open regulatory applications (INDs and NDAs) with an emphasis on high-quality, timely submissions to Regulatory Agencies (primarily FDA). Submissions include IND's and NDA's (including 505(b)(2)), Annual Reports, amendments, Clinical Trial Applications, IND/NDA supplements, expedited program designation requests, and Pediatric Study Plans. Lastly, this role will coordinate, guide, and oversee global health authority interactions and regulatory submissions with the support of partners and regional vendors.
Responsibilities
Executes the defined regulatory strategy across the product portfolio. Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives. Represents Regulatory Affairs within project teams and provides regulatory guidance to R&D, Clinical, Quality and Operations teams, as appropriate. Provides guidance to teams and peers to solve problems, achieve goals and meet company defined timelines. Provides clear communication of regulatory risks associated with development activities. Provides regulatory guidance and recommendations in support of company goals. Must exercise judgment within defined procedures and policies to determine appropriate regulatory direction and communicate to stakeholders. Serves as primary point of contact with FDA project manager for assigned projects. With minimal supervision, leads the preparation of responses to Health Authorities (US and Global). Liaises and orchestrates meetings with cross-functional teams. Participates in product team meetings (development and marketed products). Ensures product team activities align with defined regulatory strategy. Reviews technical documents for submission in new INDs, NDAs and provides guidance to the technical development teams. Authors and prepares original INDs/NDAs and amendments for submission to regulatory authorities. Manages day-to-day regulatory activities for assigned projects. Prepares both major and routine submissions to regulatory applications. Qualifications
Minimum of a bachelor’s degree in a science-related discipline; RAC certification is a plus. Global regulatory experience in ICH regions and Canada is a plus. 10 to 15 years of relevant regulatory experience in pharmaceutical/biotechnology with extensive knowledge of all aspects of the drug development lifecycle. Must demonstrate recognized leadership qualities in previous roles. Strong project management skills are a plus. Strong knowledge of current US and global regulations and guidances. Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations teams. Proven ability to communicate with executive management and external thought leaders. Demonstrated identification of key regulatory risks. Must be well organized, detail-oriented, and can multi-task and manage changing priorities. Additional Information
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please note: Aquestive is a drug-free workplace and has a drug-free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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Executes the defined regulatory strategy across the product portfolio. Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives. Represents Regulatory Affairs within project teams and provides regulatory guidance to R&D, Clinical, Quality and Operations teams, as appropriate. Provides guidance to teams and peers to solve problems, achieve goals and meet company defined timelines. Provides clear communication of regulatory risks associated with development activities. Provides regulatory guidance and recommendations in support of company goals. Must exercise judgment within defined procedures and policies to determine appropriate regulatory direction and communicate to stakeholders. Serves as primary point of contact with FDA project manager for assigned projects. With minimal supervision, leads the preparation of responses to Health Authorities (US and Global). Liaises and orchestrates meetings with cross-functional teams. Participates in product team meetings (development and marketed products). Ensures product team activities align with defined regulatory strategy. Reviews technical documents for submission in new INDs, NDAs and provides guidance to the technical development teams. Authors and prepares original INDs/NDAs and amendments for submission to regulatory authorities. Manages day-to-day regulatory activities for assigned projects. Prepares both major and routine submissions to regulatory applications. Qualifications
Minimum of a bachelor’s degree in a science-related discipline; RAC certification is a plus. Global regulatory experience in ICH regions and Canada is a plus. 10 to 15 years of relevant regulatory experience in pharmaceutical/biotechnology with extensive knowledge of all aspects of the drug development lifecycle. Must demonstrate recognized leadership qualities in previous roles. Strong project management skills are a plus. Strong knowledge of current US and global regulations and guidances. Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations teams. Proven ability to communicate with executive management and external thought leaders. Demonstrated identification of key regulatory risks. Must be well organized, detail-oriented, and can multi-task and manage changing priorities. Additional Information
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please note: Aquestive is a drug-free workplace and has a drug-free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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