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.
Job Description
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 strategy. 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
Leads 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 change control and Regulatory 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
Jazz Pharmaceuticals, Inc Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Jazz Pharmaceuticals, Inc and has not been reviewed or approved by Jazz Pharmaceuticals, Inc.
-
Fair & Transparent Compensation — Fair & Transparent Compensation: Pay is considered competitive to strong versus biopharma peers, reinforced by market-competitive ranges in public postings. Company materials emphasize a robust total-rewards mix of base, bonus, and equity.
-
Parental & Family Support — Parental & Family Support: Global paid child-bonding leave for all parents and paid caregiver leave are explicitly offered. Additional paid time elements like bereavement and a Global Volunteer Day expand family and life-event support.
-
Wellbeing & Lifestyle Benefits — Wellbeing & Lifestyle Benefits: A market-leading mental-health program provides extensive counseling and coaching access via Lyra. A Wellbeing Reimbursement Account and wellness resources broaden everyday lifestyle support.
Jazz Pharmaceuticals, Inc Insights
Similar Jobs
What We Do
Jazz Pharmaceuticals plc (Nasdaq: JAZZ), is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are focused on developing life-changing medicines for people with serious diseases—often with limited or no options—so they can live their lives more fully. By transforming biopharmaceutical discoveries into novel medicines, we are working to give people around the world the opportunity to redefine what’s possible – to make the “small wins” big again. Founded in 2003 and headquartered in Dublin, Ireland, Jazz Pharmaceuticals has a significant corporate presence in Palo Alto, CA, Philadelphia, PA and Oxford, England, with manufacturing facilities in Ireland and Italy. We maintain a highly collaborative culture where employees focus on how they can be successful and accomplish positive results by exemplifying the company’s core values: integrity, collaboration, passion, innovation and the pursuit of excellence. Together, we are more than 3,100 experts, analysts, specialists, advocates, scientists and professionals all with diverse backgrounds and perspectives. Working together, we are proud to support patients, innovate and bring new medicines to market. For more information, please see our website at www.jazzpharma.com and follow us on Twitter at @JazzPharma. For information on fraudulent schemes involving our company name and recruitment, please visit https://bit.ly/2J1EjMA. For guidelines on engaging with Jazz on social media, please visit https://bit.ly/2OaMOuq.
