Manager, Regulatory Registration and Compliance

The Manager, Regulatory Registration and Compliance is responsible for developing the strategy based on regulatory requirements and for preparing/reviewing relevant Project Plans, joint operating procedures, and/or templates. They actively assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets. This role also provides strategic regulatory guidance, training, coaching, and mentoring to junior members; may be required to line manage members of staff.

• Lead and coordinate complex regulatory projects, ensuring timely, high-quality delivery and compliance with regulatory requirements.
• Develop regulatory strategies, manage project setup activities, and provide expert guidance to internal and external stakeholders.
• Prepare, review, and oversee regulatory submissions and documentation for FDA, EMA, and other health authorities.
• Identify and mitigate risks, resolve project issues, and ensure adherence to company processes and standards.
• Manage project resources, budgets, and team performance to meet agreed timelines and objectives.
• Support business development through proposal development, budgeting, and client engagements.
• Mentor and coach junior team members to support their development.
• Build and maintain strong relationships with clients, partners, and internal stakeholders.
• Monitor regulatory intelligence and communicate relevant regulatory and legislative updates.
• Support client qualification, audit and inspection readiness, and responses to findings.
• Oversee vendor qualification and performance, ensuring compliance with company standards.
• Drive process improvements and lead departmental and organizational change initiatives.