Senior Manager, Regulatory Affairs

The Role:

Reporting to the Director, Global Regulatory Affairs, the Senior Manager, Regulatory Affairs role will integrate regulatory strategic development, submission management expertise, and hands-on execution to support the IND/CTA stage of development through NDA/MAA.

The Senior Manager, Regulatory Affairs will contribute to the development and implementation of regulatory strategy as a member of the global regulatory affairs function and clinical study team(s). This role will manage the process for preparation, submission and internal review and approval of regulatory documents, including providing technical regulatory input for global documents to streamline development.

The Senior Manager, Regulatory Affairs must be kept current, innovative, and compliant with the constant changing Health Authority requirements to facilitate regulatory processes and compliance maintenance from IND/CTAs through NDA/MAA.

Responsibilities:

• Participates as a regulatory representative for Clinical Study Team (CST) on development programs assigned working closely with product development team (PDT) lead to develop the global regulatory strategy; work closely with regulatory operations and program management to track timelines and ensure deliverables are achieved
• As part of the regulatory clinical study team, you will support preparation, review, compilation, and execution of submissions for regulatory agencies for US and ROW (e.g., IND/CTAs, NDA/MAA, DSURs, Amendments, and Responses to Regulatory Agency Requests for Information, etc.)
• Provide regulatory guidance and support to senior regulatory affairs members on various projects, as needed, to further development programs (pediatric development planning, regulatory interactions, NDA planning)
• Ensure collaboration with and coordination of cross-functional project teams for timely execution of regulatory submissions, maintaining compliance with global regulatory standards and commitments, and providing regulatory guidance and oversight
• Support regulatory operations during the regulatory submissions handoff process, as the primary point of contact for external publishing vendors, ensuring submission packages are accurate, formatted correctly, and validated.
• Maintain the regulatory information system and ensure proper archiving, searchability, and accessibility of regulatory content including correspondence with regulatory agencies
• Manage regulatory submission processes, develop and maintain regulatory tracking tools and infrastructure, as assigned Conduct regulatory intelligence and competitive intelligence and summarize key impacts to global strategy development teams, as appropriate
• Ensure compliance with internal SOPs, regulations and applicable laws. Drafts and reviews Regulatory Affairs SOPs and work instructions and provides Regulatory feedback on other departmental SOPs, where required

Competencies Include:

• Excellent attention to detail and ability to complete efficient and detailed technical data review
• Excellent organization, communication, and multi-tasking skills
• Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships
• Strong desire to contribute as a member of an engaged and collaborative cross-functional project development team