Manager, Regulatory Operations

This is a fully remote position, open to applicants in California.

📋 Description

• Provide assistance to cross-functional teams with activities related to regulatory submissions.

• Aid in the preparation, publication, and compilation of regulatory submission documents for IND, NDA/BLA, MAA, Swissmedic, CTA, and NDS applications.

• Analyze and enhance processes that support business requirements using the Veeva Vault RIM suite.

• Format intricate Word documents, which include tables and graphs, while adhering to regulatory style and submission templates.

• Keep literature lists updated and procure literature copies for regulatory submissions.

• Format, edit, proofread, and create bookmarks and hyperlinks following guidelines and internal protocols.

• Ensure uniformity across all regulatory submission documents.

• Assist with regulatory lifecycle maintenance submissions for IND and BLA applications.

• Conduct final quality assessments of published documents and submissions prior to distribution.

• Preserve and archive regulatory information, correspondence with Health Authorities, submission records, and final published files within Veeva Vault RIM.

• Stay updated on global regulatory submission requirements, eCTD standards, electronic submission specifications, and Health Authority guidelines.

• Execute other assigned tasks as needed.

⛳️ Requirements

• A bachelor’s degree along with 5-6 years of experience in Regulatory Operations, particularly with expertise in electronic submissions.

• Extensive hands-on experience and advanced skills in word processing, formatting, and PDF publishing for electronic submissions.

• Relevant experience with electronic document management and publishing systems, including Veeva Vault RIM, Box, SharePoint, Lorenz DocuBridge, eCTD validation and viewing tools, and TRS Toolbox.

• Experience with global regulatory submissions or other directly related experience in Regulatory Operations.

• Proficiency in MS Word and Adobe is essential.

• Familiarity with Accenture StartingPoint Templates is an advantage.

• Dedicated to delivering high-quality and timely outputs.

• Capability to work independently and effectively with Regulatory Affairs.

• Demonstrates flexibility, patience, and possesses strong verbal, written, and interpersonal communication skills.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity.

• Ongoing performance-based equity.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) match.

• Flexible time off.

• Paid holidays.