Jazz Pharmaceuticals · 2 days ago
Senior Manager, Regulatory Affairs
Philadelphia, PA
Full-time
Onsite
Senior Level
$140K/yr - $210K/yrJazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for serious diseases. The Senior Manager, Regulatory Affairs Global CMC will be responsible for CMC regulatory support of commercial and development projects worldwide, ensuring compliance and managing regulatory assessments for commercial products.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Ensure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments. Coordinate with other team members to manage regulatory assessments for changes for commercial products
Manage GRA CMC document lifecycles in electronic documentation system, including maintenance of document content, format(s) and metadata
Maintenance of current regulatory product information to support product release for assigned commercial products –including the management and maintenance of GRA CMC information (as per IDMP) within electronic regulatory information management system
Coordinating planning, writing and reviewing CMC information for all regulatory compliance submissions and notifications (Annual Reports, Renewals, Notifications and YPBRs) for assigned commercial products
Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies (through application of professional/technical expertise and team procedures) for commercial products under the supervision of GRA-CMC leadership
Through the performance of risk assessments, work with GRA-CMC leadership to identify and communicate potential risks associated with strategy scenarios to the multi-disciplinary team(s)
Support EU, US and global commercial license maintenance
Coordinate the preparation of documents and publishing requests to support responses to regulatory agencies, under the supervision of GRA-CMC Leadership. Manage timelines to ensure approvals are timely and development objectives are met
Effectively communicate with multiple cross functional teams in support of Regulatory CMC at internal meetings for assigned commercial products
Verify electronic publishing of regulatory submissions
Support GRA-CMC team projects in the authoring of Module 3 CTD documents including health authority responses, as required
Support continuous improvement opportunities for the GRA-CMC and the broader GRA team
Ensure compliance with company policies, procedures and training expectations
Support the writing and implementation of new procedures and processes in GRA team
Qualification
Required
Solid understanding of quality management systems including change controls, documentation management systems and experience with electronic Common Technical Document eCTD submissions
Previous experience with regulatory information management systems would also be of advantage
Solid working knowledge of CMC regulatory and ability to generate clear, well-argued positions
Must have experience with CMC regulatory documents (variations, supplements etc.)
Knowledge of FDA, EMA and ICH guidelines
Exceptional interpersonal and communication skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
BSc/BA with regulatory CMC experience
English language - written and verbal communication skills
Benefits
Medical, dental and vision insurance
401k retirement savings plan
Flexible paid vacation
Company
Jazz Pharmaceuticals
Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments.
Founded in 2003
1001-5000 employees
H1B Sponsorship
Jazz Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (24)
2023 (25)
2022 (31)
2021 (21)
2020 (39)
Funding
Current Stage
Public CompanyTotal Funding
$2.81BKey Investors
Longitude CapitalKohlberg Kravis Roberts
2024-09-03Post Ipo Debt· $850M
2021-04-22Post Ipo Debt· $1.5B
2009-12-07Post Ipo Debt· $120M
Leadership Team
Renée Galá
President and Chief Executive Officer
Ryan Bovia
Senior Vice President, Franchise Head Epilepsy and Movement Disorders
Recent News
2026-01-06
Company data provided by crunchbase