Senior Regulatory Writer

A leading regulatory consultancy is currently seeking a dynamic and experienced Senior Regulatory Writer to join their team. As a Senior Regulatory Writer, you will utilize your technical and scientific expertise to develop high-quality regulatory documents while providing leadership and guidance to a small group of direct reports.

Key Responsibilities:
Lead, manage, and motivate the regulatory team, ensuring adherence to company policies and procedures.
Coach and mentor junior regulatory team members, offering support and guidance on client and project-related matters.
Act as the primary point of contact for specific project deliverables, providing technical and scientific leadership to designated client accounts/teams and serving as a key source of product/therapy area expertise.
Take ownership of multiple projects across client accounts, ensuring the production of clear, accurate, and grammatically correct written work that meets project briefs, timelines, and budgets. Provide guidance and support to junior colleagues.
Apply your regulatory process knowledge to efficiently take documents from inception to sign-off, maintaining high-quality standards. Offer guidance to junior writers through document review.
Collaborate with the Project Management team to develop or review budgets, track project finances, and manage project schedules. Liaise with clients to negotiate changes to project specifications/budgets, if necessary.
Proactively share knowledge and experience to foster knowledge transfer within the team.
Efficiently manage project resourcing, balancing competing projects, and collaborating with the Regulatory Writing Director to engage freelancers when needed. Communicate capacity or bottlenecks to senior colleagues for optimal resource allocation.
Identify and communicate potential new projects to senior colleagues, contributing to the organic growth of the business.
Support senior team members in new business activities, such as contributing to pitches, proposals, or credentials presentations as appropriate.
Assist in the development and implementation of regulatory processes, document quality, regulatory strategy, and client procedures. Lead by example, implementing best practices and advising on project approaches and compliance requirements.

Company Standards:
Promote the company's mission, vision, and values in all aspects of your work.
Conduct yourself in accordance with the company's Code of Conduct, as outlined in the Employee Handbook.