Associate Director, Regulatory Writing
Role Purpose
Lead the development of high-quality regulatory documentation, ensuring outputs meet or exceed client expectations, are delivered on time and within budget, and provide meaningful value to clients and the broader business. Operate independently or collaboratively as needed, demonstrating initiative, adaptability, and a proactive, solutions-oriented mindset.
Core Responsibilities
Regulatory Writing, Briefing & Review
- Lead the development of a wide range of high-quality regulatory documents.
- Oversee and manage diverse projects, providing strategic and technical guidance to team members.
- Rapidly interpret clinical development data and critically assess source materials.
- Produce clear, accurate, and high-quality documentation under tight timelines.
- Apply in-depth understanding of regulatory authority expectations and client requirements to guide document strategy and execution.
- Provide clear briefs to team members, including scope, timelines, and document requirements.
- Review deliverables to ensure compliance with regulatory standards and client expectations, focusing on clarity, accuracy, and suitability.
- Manage workload effectively across competing priorities, proactively identifying and resolving risks.
- Perform detailed data verification and quality checks on documentation.
- Participate in training programs and contribute feedback to support continuous improvement.
Leadership & Team Development
- Identify opportunities to delegate work across team levels appropriately.
- Mentor senior writers and coach junior team members, supporting their professional development.
- Contribute to onboarding and training of new regulatory writers.
- Promote best practices, consistency, and knowledge sharing across the team.
- Partner with line management to support capability development and training plans.
Client Engagement
- Build and maintain strong client relationships as a trusted, knowledgeable point of contact.
- Lead client meetings and facilitate effective communication and decision-making.
- Anticipate client needs and provide strategic input to address challenges and deliver solutions.
- Develop a strong understanding of project and submission strategies.
- Support long-term client partnerships through ongoing project involvement.
Commercial & Financial Management
- Demonstrate strong awareness of project budgets, scope, and financial performance.
- Collaborate with senior stakeholders to identify and address commercial risks.
- Ensure accurate and timely completion of timesheets and achievement of utilization targets.
Business Development
- Support business development efforts by contributing to new client relationships.
- Collaborate with internal and external partners to expand opportunities.
Additional Responsibilities
- Champion organizational values and contribute to a positive team culture.
- Undertake additional duties as reasonably required.