Director, Regulatory Affairs

Join a visionary team as a Director, Regulatory Affairs at Allucent, where you will lead complex regulatory initiatives across drug, biologic, and medical device programs, partnering with global clients to navigate development and Health Authority interactions with confidence and precision. This is a high-impact leadership role for a regulatory expert who thrives on shaping strategy, mentoring teams, and delivering scientifically sound submissions that drive successful product approvals.

As a Director, Regulatory Affairs, you will serve as a strategic leader and subject matter expert, guiding global regulatory activities across drug, biologic, and medical device programs from development through lifecycle management. In this role, you will lead Health Authority interactions, provide expert regulatory guidance, and oversee the preparation, review, and strategy for high-quality regulatory and scientific submissions, ensuring compliance with global regulations and CTD requirements. The Senior Director also plays a critical role in mentoring teams, shaping regulatory strategy, supporting due diligence and client consulting activities, and translating complex regulatory requirements into clear, practical plans that enable successful product development and approvals.

Key Responsibilities:

• Lead global regulatory strategy for drug, biologic, and medical device programs, including oversight of Pre-IND, IND, NDA, and BLA filings, ensuring compliance across all phases of development through post-approval lifecycle management
• Serve as the primary regulatory subject matter expert, leading Health Authority interactions, including meeting preparation, briefing documents, and direct participation in agency meetings and correspondence
• Oversee the preparation, review, and authoring of regulatory and scientific submissions, ensuring documents are accurate, well-organized, and aligned with global regulatory requirements and CTD standards
• Provide strategic regulatory guidance to clients and project teams, translating complex regulatory requirements into clear, practical plans that support successful product development and approvals
• Guide and mentor regulatory team members, reviewing work, providing technical direction, and ensuring high-quality deliverables across multiple projects and clients
• Contribute to high-level project and business activities, including due diligence reviews, regulatory risk assessments, change impact evaluations, and strategic consulting support for clients

Requirements

About You

We are seeking a results-oriented leader with a passion for regulatory affairs, deep industry knowledge, and the ability to drive teams towards excellence in a challenging landscape. You should possess:

• Advanced degree (Ph.D., M.D., or equivalent) or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
• Advanced regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for US, EU, and/or Canada
• 10 years’ experience with regulatory requirements of US FDA, Health Canada and/or European authorities
• Strong analytical and strategic thinking skills, with the ability to navigate complex regulatory environments
• Exceptional communication and leadership skills, with a drive to mentor and guide a team