Senior Manager, Regulatory Operations

About the role

The Senior Manager, Regulatory Operations supports the Nurix Regulatory Affairs department. They provide key support to the Regulatory team, project teams, and CRO counterparts in the implementation of regulatory plans, timely delivery, and submission of regulatory documentation.

Responsibilities

• Support the planning, coordination, tracking, and execution of submissions and responses to global regulatory authorities under the strategic direction of the SVP of Regulatory Affairs and the Director of Regulatory Affairs PM and Operations.
• Aid the Regulatory team, project teams, and CRO counterparts in the implementation of regulatory plans, timely delivery, and submission of regulatory documentation.
• Prepare Regulatory submission documentation (e.g., Forms, Cover Letter) as requested.
• Support the team with formatting, quality control (QC), and publishing of submission documents and packages.
• Manage and support Veeva RIMS processes such as HAI, SCP, and Archiving.
• Manage authoring and review workflow in Veeva RIMS according to defined timelines.
• Cook up and coordinate with regulatory colleagues and cross-functional departments to prepare, compile, review, and submit documents or information necessary to health authorities in accordance with regulations, guidelines, or queries in Veeva RIMS using SCP.
• Maintain archival copies of health authority submissions (e.g., IND, CTA, NDA, and MAA), correspondence, and a record of health authority obligations and commitments.
• Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration. Participate in Regulatory Intelligence activities to help inform team members of new applicable guidelines and conduct training sessions on new guidelines/regulations if necessary.
• Participate in kick-off and project-based meetings related to regulatory submissions, strategy, and comment resolution. Be a reliable resource for information following such meetings.
• Follow general instructions from Regulatory management or company leadership for assigned projects while independently planning daily work tasks to complete projects on time. Seek guidance on project/task priorities as needed.
• Communicate important project decisions or challenges to Regulatory leadership.
• Create or contribute to Standard Operating Procedures (SOP), checklists, and training materials for Regulatory department activities.
• Support contracts and Purchase Orders for the Regulatory Affairs department.

Requirements

• Bachelor's Degree in Life Sciences or relevant field.
• Minimum of 5 years’ experience working in Regulatory Affairs or Regulatory Operations. Additional experience in the biotechnology or pharmaceutical industry preferred.
• Understanding of the drug development process.
• Proficient knowledge of Veeva RIMS SCP, workflows, archival, reporting...
• Experienced publisher (DocuBridge, GlobalSubmit, VeevaVault Submission...)
• Experience successfully supporting critical deliverables while maintaining agreed timelines.
• Demonstrated ability to work effectively with cross-functional teams or collaborative environments.
• Basic knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines.
• Previous experience with building electronic submissions in compliance with Health Authority requirements is a plus.
• Previous experience with maintaining in-house repository for archiving regulatory submissions and Health Authority correspondence in 21 CFR Part 11 compliant system (e.g., Veeva) is a plus.
• Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
• Superior communication skills: oral, written, with proven negotiation skills, and strong time-management.
• Excellent Computer Skills MS Word, Excel, Power Point, Smartsheet and document management software/system, templates.
• Ability to work on multiple tasks and prioritize tasks to meet company objectives. Strong attention to detail and time management skills are essential.