The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The Director, Regulatory Affairs, with a focus on combination products, will define, develop, and lead combination product strategies to maximize regulatory success, strengthen the product development plan, and enable patient access in alignment with program objectives.
Defines, develops, and leads combination product regulatory strategies to maximize regulatory success towards achievement of program objectives.
Manages, plans, and directs all aspects for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned programs.
Stays current with combination product regulations for impact on drug development plans, registration, and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance.
Manages all Regulatory responsibilities for assigned manufacturing changes and new product launches, including but not limited to: developing and executing process validation protocols and publishing reports; develop area, process, and supplier quality plans and out of control action plans; implement Statistical Process Control (SPC) in manufacturing processes where applicable.
Provides strategic guidance and advice on emerging trends with respect to combination product regulations and changes.
Provides regulatory support and leadership for all Design Control activities.
Participates in interactions with FDA and other Health Authorities for all company combination products.
Bachelor’s Degree in a scientific, engineering, industrial design, or similar discipline is required; advanced degree preferred.
10+ years of experience with increasing responsibility years working with medical, commercial, or industrial products from pharmaceutical, regulatory, design, testing, validation, ergonomics, and human factor perspective.
The ideal candidate will have a combination of regulatory, pharmaceutical, device design, testing, human factors, and usability expertise in a regulated environment.
Experience with Health Authorities, Verification & Validation protocols, and test reports.
Experience with device regulatory requirements and development processes for combination products.
Experience writing technical documents such as test reports, technical memos, input requirements documents, human factors protocols, etc.
Experience preparing information for NDA, BLA, 510k, IDE, and PMA submissions is a plus.
Strong knowledge of regulations, current industry practices, and interpretation and application practices.
Competencies: Analytical skills, Risk Management, Attention to Detail, Strategic Leadership, Presentation skills, Facilitation skills, Written and Verbal Communication skills, Teamwork & Collaboration skills, Organizational skills
Position may require periodic evening and weekend work, as necessary to fulfill obligations.
U.S. and International travel approximately 20%.
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
Internal Number: 2021-1291
About Xeris Pharmaceuticals
Xeris is a specialty pharmaceutical company leveraging novel formulation technology platforms to develop and commercialize ready-to-use, liquid-stable injectables.