Director, Regulatory Operations

Overview

Reporting to the Head of Regulatory Affairs, this role establishes and leads Regulatory Operations for the organization. The Director of Regulatory Operations will support growing regulatory needs, including internal publishing and coordination with multiple external vendors.

Responsibilities

• Oversee all Regulatory Operations deliverables, including:
  • Management of Health Authority correspondence/submission archives
  • Business administration of the Veeva Vault Regulatory Information Management system
  • Submission management
  • Training of associated business processes
• Implement training strategies, develop training materials, and lead training delivery for effective adoption of Vault RIM
• Manage user groups and workflows and create and maintain archives of Health Authority interactions
• Develop, manage, and distribute reports, dashboards, and templates to meet user needs
• Contribute to writing, reviewing, and implementing standards and procedures related to regulatory information management
• Partner with IT and Quality to support system validation activities
• Maintain proficiency in Vault RIM and stay current on regulations, best practices, and guidelines related to RIM
• Provide eCTD/CTD publishing services, including:
  • Rendering, bookmarking, hyperlinking
  • Compilation
  • Table of contents creation
  • QC of regulatory submissions to regulatory agencies
• Coordinate publishing deliverables and serve as the primary point of contact across regulatory functions (Regulatory Affairs, CMC, Labeling, etc.) for major submissions (IND, BLA, etc.)
• Write or review internal work instructions and standard operating procedures (SOPs) pertaining to submission preparation (electronic or paper)
• Create, update, and maintain submission templates that meet global regulatory requirements

Requirements

• BA/BS or equivalent experience
• At least 12+ years of industry experience with at least 7+ years of regulatory operations experience
• Strong attention to detail and the ability to work independently, within a multi-disciplinary team, and with external partners and vendors
• Prior experience running large scale RA projects within the biotech industry
• Extensive knowledge of eCTD and e-publishing systems for preparing regulatory submissions, as well as regulatory management systems (e.g., Veeva RIM)
• Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat, and Veeva Vault RIMs
• Ability to thrive in a collaborative and fast-paced team environment

Compensation & Benefits

This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.

• Potential base pay range: $206,000—$227,000 USD

Equal Employment Opportunity

The organization is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including sexual orientation and gender identity), national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Recruitment & Staffing Agencies

The organization does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the organization’s Human Resources Department will be considered property of the organization, and no fee shall be owed with respect thereto.