Senior Manager Regulatory Affairs

About the job

An EU-based Biotechnology research company is pioneering copper-based theranostics with its platform, developing a fully integrated diagnostic and therapeutic approach using Copper-61 (PET imaging) and Copper-67 (therapy). They are advancing a differentiated clinical pipeline targeting solid tumours with high unmet need while building a sustainable, global radionuclide production and manufacturing network. Following a Series B financing, the company is scaling its operations across Europe, North America and beyond.

In this role

you will oversee and execute the company's regulatory strategy throughout product development, from preclinical to phase III. You will play a critical role in ensuring successful regulatory filings and supporting interactions with global health authorities, including the FDA and EMA.

Your responsibilities

• Develop, lead, and implement global regulatory strategies for our pipeline products, with a focus on alignment with FDA/EMA and other international regulatory requirements.
• Lead the preparation and submission of all regulatory filings (INDs, NDAs, Scientific Advice and related submissions).
• Ensure compliance with all applicable regulatory requirements throughout the Clinical Development Program of each product.
• Serve as the primary liaison for regulatory agencies (FDA, EMA, etc.), managing communications and agency interactions.
• Identify regulatory risks and provide strategic guidance on risk mitigation, regulatory pathways, and opportunities to accelerate development timelines.
• Establish scalable regulatory processes and policies to support product development objectives.
• Collaborate cross-functionally with Medical, Clinical, Quality, and Manufacturing teams.

Your profile

• Advanced degree (PhD, PharmD, MD, or equivalent).
• 10+ years of Regulatory Affairs experience in biotech/pharma; significant biotechnology experience is a must.
• Proven track record with FDA and EMA submissions and approvals (IND, NDA, Scientific Advice, etc.).
• In-depth understanding of global regulatory standards and processes, and experience across phase I-III drug development.
• Strong strategic mind with the ability to manage complex projects, interpret regulatory guidelines, and provide actionable recommendations.
• Excellent communication skills in English, written and verbal.

Don't miss this unique opportunity to contribute to cutting-edge precision oncology. Apply now and embark on an exciting journey. We welcome applicants from diverse backgrounds who are enthusiastic and passionate about this field.