Senior Associate, Regulatory Affairs

The Senior Associate, Regulatory Operations will report to the Director of Regulatory Operations and will support various regulatory activities. The Senior Associate will work with members of the Regulatory group, other departments, and vendors to manage regulatory requirements and submissions.

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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $125,600-$177,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.