Chiesi USA, Inc. · 1 week ago
Sr. Manager, Regulatory Affairs
California, United States
Full-time
Hybrid
Mid, Senior Level
$121K/yr - $182K/yr
5+ years expChiesi USA, Inc. is an international research-focused biopharmaceutical group with a commitment to promoting a healthier world. They are seeking a Senior Manager for Regulatory Affairs to develop regulatory strategies for the North America region and manage regulatory submissions for GRD products.
BiotechnologyMedicalPharmaceutical
Responsibilities
In collaboration with consultants, partners and affiliates, plans, coordinate, and manage regulatory submissions to regional agencies throughout the life cycle of GRD products
Provide advice and guidance regarding regional regulatory requirements on assigned multidisciplinary project teams driving the development and geographical expansion of GRD products
Contribute to the preparation and/or review of submissions to relevant markets to ensure high quality of the documentation
Communicate directly with regional regulatory authorities on behalf of Chiesi GRD unit to negotiate strategies and actions associated with regulatory submissions
Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., makes recommendations for improvement and ensures adequacy for submission
To be delegated to the development of processes and to the preparation of Standard Operating Documents for GRD Regulatory Affairs, where needed
Provide regulatory guidance to colleagues from other functional areas
Provide regulatory expertise in support of due diligence assessments
Represent the Regulatory Department at the Core Team as global Regulatory Affairs member, where needed
With supervision of the line manager, coordinate the preparation of the needed documents for the scientific advice and lead discussions with regional regulatory agencies
Qualification
Required
5-7 years of experience in corporate regulatory affairs roles with an in-depth knowledge of the drug development
Experience and knowledge in new MAAs and in the life cycle management of registered MAs
Ability to work independently in the preparation of high-quality submissions and submission documents
Strong attention to details and quality of the documentation and processes
Well-developed written and oral communication and listening skills
Well-developed time management skills and demonstrated ability to manage complex assignments
Experience in leadership and coaching is an asset
Well-developed analytical and problem-solving skills
Ability to work independently and as part of a team
Life Science Degree
Benefits
Comprehensive healthcare programs
Work-life balance initiatives
Robust relocation support
Performance bonuses
Flexible working arrangements
Remote work options
Tax assistance services for foreign colleagues
Company
Chiesi USA, Inc.
Chiesi USA is a pharmaceuticals company specializing in pharmaceutical research & development services.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$0MKey Investors
North Carolina Biotechnology Center
2020-08-04Grant· $0M
Leadership Team
Jon Zwinski
Chief Executive Officer - General Manager
Molly Rice
Senior Human Resources Business Partner / Associate Director Human Resources
Recent News
Clinical Trials Arena
2024-05-24
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