If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

​ ​ ​ ​ The Associate Director position, Regulatory Affairs Global   CMC   is responsible for   establishing   global regulatory CMC Strategies for commercial and development projects   in line with the global regulatory   strateg y .     The Associate Director will have a strategic role in driving CMC Regulatory Strategies across multi-disciplinary teams , including leading the preparation of regulatory CMC submissions .   ​ ​ ​ ​ Essential Functions ​ Lead s   activities that include planning   content , authoring where   appropriate ,   reviewing   and approval of   Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), in support of Global Regulatory Team Objectives.

​ Provide in-depth reviews of protocols, reports, presentations, and documents for CMC Development or Commercial product team, as   required .

​ May   represent   Reg- CMC   at   related regulatory agency interactions for team   products ,   and   manage the preparation and review of material for agency interactions .

​ Provide   timely   updates   of   CMC Regulatory Strategy for the Global Regulatory Strategy document for assigned projects, as   required   and securing functional support.

​ Lead   the preparation and submission of responses to regulatory   agencies   are managed appropriately and in   a timely   fashion.

​ Regularly interact with functional leaders, on matters concerning CMC regulatory strategy, including regulatory agency interactions   to ensure functional alignment .

​ Lead GRA-CMC or GRA projects / initiatives that significantly   impact   the business globally.

​ Identify   and lead continuous improvement opportunities for the GRA-CMC team and the broader GRA team.

​ Ensure continued regulatory compliance of products   though   adherance   to   c hange control and Regul a tory Information Management procedures, completing the regulatory impact assessment of changes and ensuring   appropriate implementation   planning is executed.

​ Ensure compliance with company policies,   procedures   and training expectations

​ ​ ​ Required Knowledge, Skills, and Abilities ​ Demonstrated understanding and strategic application of regulations and guidelines for drug   lifecycle activities .

​ Demonstrated knowledge of CMC regulatory and ability to generate clear, well-argued positions.

​ Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations,   responses   and CTAs/INDs).

​ Demonstrated understanding of FDA,   EMA   and ICH guidelines.

​ Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.

​ Demonstrated ability to influence and   impact   their functional area and department practices.

​ ​ ​ Required/Preferred Education and Licenses ​ BSc/BA with regulatory CMC   experience.

​Fluent English language - written and verbal communication skills .

#LI-Remote #LI-SM1 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. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html .