Senior Associate, Regulatory Affairs

Responsibilities:

• Compile, format, and publish electronic regulatory submissions to health authorities
• Supporting Regulatory Operations members with maintaining the Veeva Vault RIM system and ensuring that all regulatory records are up to date
• Supporting GxP change control processes in Veeva Vault
• Supporting the QC of regulatory documents prior to submission to health authorities
• Collaborate with external publishing vendors for e-submission files and submission receipts
• Managing the tracker with all weekly/monthly regulatory submissions and communicating information with the Regulatory group
• Maintaining templates and style guides for regulatory submissions
• Participating in the development of Standard Operating Procedures (SOPs)
• Supporting Regulatory team members with regulatory filings and projects, as needed

Preferred Skills, Qualifications and Technical Proficiencies:

• Experience with Veeva Vault systems is preferred
• Experience with electronic submissions to the EU health authority is a plus
• Detail oriented with excellent oral and written communication skills
• Strong team player, self-motivated and able to function independently as well as part of a team
• Able to work on multiple projects concurrently and adapt to a continuously changing environment
• Proficient in organization, prioritization, and time management
• Experience with Microsoft Word, PowerPoint and Excel

Preferred Education and Experience:

• BA/BS degree in a scientific discipline
• 3+ years of relevant regulatory experience in the pharmaceutical industry