Senior Manager, Regulatory Operations
3 weeks ago
Senior Manager, Regulatory Operations
This role, reporting to the Director of Regulatory Operations, entails overseeing the regulatory archives within the Veeva Vault system and internal shared drive. The Manager/Senior Manager will collaborate with a multifaceted team, providing essential support for regulatory filings and projects.
Responsibilities include:
- Maintaining regulatory records within the Veeva Vault RIM system
- Managing the change control process in Veeva Vault RIM
- Ensuring up-to-date US/ex-US submissions and correspondence files within the Regulatory shared drive
- Collaborating with external publishing vendors for e-submission files and receipts
- Managing the spreadsheet tracking weekly/monthly regulatory submissions and communicating with external publishing vendors
- Maintaining templates and style guides for regulatory submissions
- Providing support to other Regulatory team members and their projects
- Participating in the development of standard operating procedures
Preferred Skills, Qualifications, and Technical Proficiencies:
- Preferably experienced with Veeva Vault systems
- Detail-oriented with excellent oral and written communication skills
- Strong team player, self-motivated, capable of working independently and collaboratively
- Ability to manage multiple projects simultaneously in a dynamic environment
- Proficient in organization, prioritization, and time management
- Proficiency in Microsoft Word, PowerPoint, and Excel
Preferred Education and Experience:
- BA/BS degree in a scientific discipline
- 5+ years’ experience in the pharmaceutical industry or life sciences, with at least 4 years in regulatory affairs
Interested? Apply here and send your CV to susan.clasby@peoplewithchemistry.com
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