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 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter.
The Senior Manager, Global Regulatory Affairs will be responsible for managing registration and regulatory support for commercial and development projects worldwide.
Manage regulatory activities to maintain EUR and INT commercial licenses.
Support EU and global clinical trials.
Support development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development, under the supervision of GRA leadership.
Through the performance of risk assessments, work with GRA leadership to identify and communicate potential risks associated with strategy scenarios to the multi-disciplinary team.
Act as regulatory representative at meetings with business partners and regulatory agencies.
Plan and co-ordinate the writing and reviewing for relevant sections of regulatory submissions (IMPDs, CTAs, MAAs, meeting requests, and briefing documents), as appropriate.
Coordinate the preparation and timely submission of responses to regulatory agencies.
Manage timelines to ensure approvals are timely and development objectives are met.
Monitor Global regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
Verify electronic publishing of regulatory submissions.
Identify & support continuous improvement opportunities for the broader GRA team.
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
Solid working knowledge of regulatory and ability to generate clear, well-argued positions.
Must have experience with electronic Common Technical Document regulatory documents
(MAA, BLA, responses and CTAs/INDs).
Demonstrated understanding of 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.
Required/Preferred Education and Licenses
Bachelors, Masters or advanced degree in a scientific discipline
English language - written and verbal communication skills.
Description of Physical Demands
Occasional mobility within office environment.
Routinely sitting for extended periods of time.
Constantly operating a computer, printer, telephone and other similar office machinery.
Some travel required.
Description of Work Environment:
Work indoors in normal office environment with little exposure to excessive noise, dust, fumes,
vibrations and temperature changes.
Frequent computer use at workstation.
May move from one work location to another occasionally.
Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an Equal Opportunity Employer.