Regulatory submission manager :: REMOTE Job at Freyr Solutions (Client: Pharmaceutical Company)
Regulatory submission manager :: REMOTE
Job Purpose A senior individual contributor position in GDD Regulatory Affairs Operations accountable for all publishing, verification, dispatch and coordination of large and complex HA compliant, worldwide regulatory submissions in support of NVS global product portfolios.
Major Accountabilities
- Manages and publishes large and complex global regulatory submission projects in eCTD and non-eCTD format (eCTD, NeeS and Paper) such as NDA/BLA/INDs, MAAs (CP, MRP, NeeS, HA AtoQ, compliance submissions, etc. in compliance with worldwide HA requirements (US, EU, LACan, MOW).
- Partners with Operations Submission Managers and a publishing team located in 3 regions (US, EU and India) and actively functions in a global capacity.
- Liaises /collaborates with cross functional team members and document authors (Project Management, Clinical, Nonclinical, CMC, Safety and Quality functions) to achieve timely dispatch of high quality large and complex submissions.
- Key contributor in internal publishing process development/implementation (process innovator) and integration activities related to acquisitions, partnerships and divestitures, etc.
- Lead coach and mentor to publishing peers and colleagues and actively demonstrates leadership skills.
- Develops and authors training materials and leads efforts to implement training to ensure optimal use of processes, and tools related to regulatory publishing activities.
- Change champion across the Operations group and beyond
Job Type: Full-time
Schedule:
- 8 hour shift
- Monday to Friday
Experience:
- FDA regulations: 4 years (Preferred)
Work Location: Remote
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