Responsible for specified regulatory deliverables for multiple development programs, working with the Global Regulatory Lead, cross-functional stakeholders and regulatory sub team members, as needed
Develop, drive and coordinate regulatory timelines, working closely with the Global Regulatory Lead and other key stakeholders
As the Regional Regulatory Lead, serve as the main point of contact with regulatory authorities, and lead region-specific regulatory authority interactions
Ensure compliance of regulatory strategies and submissions with current regulations and guidance
Represent US regulatory affairs on global regulatory subteam, providing updates on US specific activities and any changes to guidelines that could impact development program.
Support Global Regulatory Lead for the molecule in developing strategies for new development projects and partnerships, as needed.
Identify and communicate potential risks associated with regulatory strategies.
Prepare IND and NDA submissions including clinical trial applications, amendments, periodic safety updates, supplements, meeting requests, briefing packages, annual reports, etc. Assist in managing internal review and submission of these items.
Lead the coordination, preparation and timely submission of regulatory documents and responses to queries from authorities Lead the coordination, preparation and timely submission of regulatory documents and responses to queries from authorities
Other duties as assigned
Experience and Education:
Minimum 5 years’ experience in Regulatory Affairs, including experience managing regulatory aspects of an IND and global clinical trial activities. BS or BA degree
Candidate must have:
Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA stages. Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance within the US; additional experience within Canada preferred Excellent written and verbal communication skills Ability to work effectively in cross functional teams Excellent organizational and time management skills, ability to manage multiple complex projects Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment Capable of strategic thinking and proposing innovative solutions to regulatory problems Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development Travel up to 10%-20% of the time
Employer will assist with relocation costs.
Internal Number: 2018-3547
About JAZZ Pharmaceuticals
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.