Associate Director Regulatory Affairs

Are you looking for an exciting opportunity to make a meaningful impact in the biopharmaceutical industry? This role offers the chance to be at the forefront of innovative medicine development within a dynamic, science-driven company. You will have the opportunity to shape regulatory strategies that accelerate the delivery of transformative therapies to patients in need, working alongside a passionate team dedicated to advancing genetic-based medicines.

Our client is a cutting-edge biopharmaceutical organization focused on harnessing human genetics to develop precision medicines for metabolic, cardiovascular, and kidney diseases. They are committed to pioneering solutions that target the underlying genetic factors of these conditions, with a focus on improving patient outcomes worldwide.

In this role, you will play a pivotal part in supporting global regulatory activities for their clinical-stage programs. Your work will directly influence the development process, from preparing regulatory submissions to managing interactions with health authorities. You will collaborate closely with cross-functional teams to ensure regulatory compliance and strategic alignment, helping accelerate the path to market.

Role Summary: This position is ideal for someone who thrives in a fast-paced environment, eager to lead regulatory initiatives that impact critical development programs. You will report to the Senior Director of Regulatory Affairs and will be instrumental in guiding regulatory strategies, managing submissions, and supporting key interactions with health authorities. The role may require onsite presence, with opportunities to interact with global teams dedicated to bringing innovative treatments to patients.

Key Responsibilities:

• Lead the preparation and management of regulatory submissions, including INDs and CTAs.
• Manage interactions with health authorities, preparing briefing documents and responses.
• Support the development of regulatory strategies aligned with company objectives.
• Collaborate across departments on clinical, nonclinical, and CMC regulatory activities.
• Provide regulatory guidance on development documents and protocols.
• Support continuous improvement of regulatory processes to enhance efficiency and compliance.
• Identify potential regulatory risks and develop mitigation plans proactively.

Experience & Requirements:

• Bachelor’s degree in life sciences; advanced degree preferred.
• 7+ years of regulatory affairs experience in the biopharmaceutical industry.
• Strong understanding of US and EU regulatory frameworks, ICH guidelines.
• Hands-on experience preparing and managing IND/CTAs; NDA/MAA experience is a plus.
• Excellent project management skills with the ability to prioritize multiple projects.
• Strong communication skills for conveying complex regulatory concepts clearly.
• Proven ability to thrive in a fast-paced environment and collaborate effectively across teams.

This role offers a base salary between $197,000 and an upper range depending on experience.

Apply now to be part of a growing team shaping the future of genetic medicine and precision healthcare.

Human Review Note:
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