Associate Director, Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Regulatory Affairs based in United States.

The Associate Director, Regulatory Affairs is a key member of a global regulatory organization, helping shape and execute regulatory strategies across the product lifecycle.
You will serve as a trusted advisor and business partner, with a strong focus on US regulatory activities and FDA engagement.
The role spans pre-approval, filing, launch, distribution, and post-approval activities for innovative medicines.
You will work closely with clinical, medical, legal, quality, pharmacovigilance, and commercial teams to support critical business decisions.
As a primary regulatory contact, you will lead agency interactions and contribute to high-quality submissions and responses.
The position combines strategic thinking with hands-on execution in a fast-paced, science-driven environment.
It offers the opportunity to influence regulatory strategy, support successful product launches, and contribute to medicines addressing significant patient needs.

• Develop and implement robust US regulatory strategies for assigned development and commercial projects.
• Provide strategic, operational, and tactical regulatory guidance across pre-approval and post-approval activities, with a particular focus on the US and regional regulatory strategy.
• Serve as a primary point of contact with the FDA and lead or participate in regulatory meetings as appropriate.
• Prepare internal teams for interactions with regulatory authorities and ensure effective coordination of agency communications.
• Lead and oversee the preparation of regulatory dossier content for INDs, BLAs, and NDAs.
• Critically review submission documents to ensure quality, consistency, and compliance with applicable regulatory requirements.
• Coordinate timely responses to FDA questions in alignment with established product and regulatory strategies.
• Contribute to labeling development and regulatory negotiation strategies.
• Provide regulatory input into clinical development and study design.
• Partner closely with medical, legal, quality, pharmacovigilance, distribution, and other cross-functional teams to ensure regulatory considerations inform business decisions.
• Monitor, interpret, and communicate changes in the US regulatory environment, legislation, and guidance.
• Assess the competitive regulatory landscape, including regulatory precedents, labeling differences, and therapeutic-area-specific considerations.
• Leverage digital technologies, AI-enabled environments, data-driven insights, and innovative tools to strengthen regulatory strategy and cross-functional alignment.
• Support strategic planning, resource allocation, prioritization, and execution of complex regulatory initiatives in a matrix environment.
• Build strong relationships across functions and provide leadership that combines strategic direction with hands-on execution.

Requirements

• Minimum 8 years of regulatory affairs experience within biopharmaceutical organizations, including 3–5 years in global leadership roles with a strong FDA focus.
• PhD or PharmD preferred.
• Experience working in rapidly growing pharmaceutical or biopharmaceutical organizations is desirable.
• Thorough understanding of the drug development lifecycle, with expertise in orphan drugs and knowledge of evolving global regulations and guidelines.
• Demonstrated experience coordinating critical regulatory documentation supporting the approval of medicines, particularly FDA-focused submissions.
• Proven experience interacting directly with regulatory authorities.
• Ability to engage effectively with scientists, clinicians, business leaders, and other stakeholders on technical and commercial topics.
• Strong understanding of current and emerging regulatory legislation, industry trends, and global healthcare business practices.
• Highly developed organizational and project management skills, including strategic planning, delegation, resource allocation, and workload prioritization.
• Strong communication and presentation capabilities, with the ability to influence stakeholders internally and externally.
• Ability to build collaborative relationships and connect teams around shared business and regulatory objectives.
• Comfortable operating in a fast-paced, results-oriented, highly accountable environment.
• Pragmatic, creative, and innovative approach, with a willingness to take a hands-on role in delivering results.
• Demonstrated leadership experience, including the ability to build, motivate, and develop teams.
• Strong strategic thinking combined with the ability to execute independently and through cross-functional teams.
• Familiarity with digital technologies, AI-enabled tools, and data-driven approaches to regulatory strategy is valued.
• Strong ability to navigate complex challenges, prioritize competing demands, and drive operational excellence.

Benefits

• Annual base salary hiring range of $164,000–$225,500 USD, with individual compensation determined based on relevant experience, skills, demonstrated competencies, and internal equity.
• Eligibility to participate in short-term and long-term incentive programs, subject to applicable plan terms and policies.
• Comprehensive benefits package, including retirement savings plans and health benefits.
• Opportunity to work in a global, science-driven environment focused on advancing innovative medicines.
• Strategic exposure across the full product lifecycle, from development and regulatory submissions through commercialization and post-approval activities.
• Close collaboration with scientific, clinical, medical, legal, quality, pharmacovigilance, and business teams.
• Opportunity to influence US regulatory strategy and lead interactions with the FDA.
• Environment that values innovation, collaboration, accountability, and professional growth.
• Remote work arrangement within the United States.