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 Senior Manager, Regulatory Strategy will be responsible for supporting product applications of all types within commercial and development projects. A Senior Manager Regulatory Affairs will be a key member of project teams and teams responsible for evaluation of product concepts.
Available to sit in:
Philadelphia, Pennsylvania, United States
Palo Alto, California, United States
Remote Non Sales-USA, California, United States
• Participate as an active member of a multi-disciplinary team to establish development and regulatory strategies for commercial products, late stage, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios
• Represent and coordinate regulatory information as a team member, covering CMC, clinical, labeling, and post-approval change activities
• Provide in-depth reviews of protocols, reports, presentations, and other documents
• Document regulatory contacts with health authorities.
• Prepare IND, NDA, and BLA submissions including original marketing applications, clinical trial applications, amendments, supplements, variations, responses to Agency questions and requests, meeting requests, briefing packages, annual reports, periodic safety reports, etc. Help manage the internal review and submission of these items.
• Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions
• Manage submission plans and timelines to ensure approvals are timely and development objectives are met
• Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
• Provide risk assessments and recommendations for various regulatory scenarios
• Participate in the electronic review and quality verification of regulatory submissions
• Manage regulatory data and information within systems
• Bachelors, Masters or advanced degree in a scientific discipline, with at least 5 years of regulatory strategy experience in the pharmaceutical industry
• Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages
• Excellent verbal and written communication skills
• Leadership ability within a multiple time zone team environment
• Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others
• Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
• Some travel will be required
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Internal Number: 5379
About JAZZ PHARMACEUTICALS INC
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.