Associate Director Regulatory Affairs

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

Remote/Commuter Opportunity - Open to candidates within the United States

The Associate Director, Regulatory Strategy provides key support to the Regulatory Affairs team and pipeline programs supporting the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological products (developmental and marketed products). The position participates on global cross‑functional teams ensuring that US requirements and expectations are achieved in an optimal and compliant manner.

• Provide regulatory support and guidance to various cross‑functional teams. Ensure all applicable regulatory requirements are considered and appropriately incorporated into activities and deliverables for clinical and commercial products and programs.
• Provide regulatory support in authoring and editing of regulatory documents (e.g. Meeting requests, query responses) as needed.
• Provide regulatory review of product documentation intended for regulatory submissions for accuracy and compliance with FDA regulations. Manage, review and represent US regulatory perspective at Regulatory Affairs Focus Team (RAFT) meetings.
• Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure compliance with regulatory obligations, relevant regulations, and guidance (e.g., ICH, FDA, EMA) prior to submission.
• Manage the processing of regulatory submissions with Strategy leadership and operational support; ensure submissions are prepared in compliance with regulatory requirements and guidance documents; ensure that appropriate review and approval is obtained.
• Proactively identify regulatory risks and provide recommendations for risk‑benefit assessments and risk mitigations.
• Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration.
• Monitor the external regulatory climate to inform internal customers of potential impact on long‑term objectives.
• Assist or lead improvement efforts supporting necessary compliance enhancements and departmental efficiencies.
• Manage assembly and creation of documentation supporting investigational and new drug application/biologic license application for the US FDA throughout the product's lifecycle.
• Provide high‑level RA advice and identify US regulatory requirements for clinical studies and marketing.
• Assess scientific data for proposed registration and labeling against current FDA guidance, regulations, and precedent.
• Facilitate policy and development of standard interpretation of US regulations.
• Maintain awareness of US regulatory legislation and assess its impact on business and Lundbeck product development programs.
• Complete internal and external training on departmental initiatives and for compliance purposes.

• Accredited Bachelor's Degree.
• 8+ years R&D experience within a pharmaceutical and/or biotech industry, with 5+ years' experience in Regulatory Affairs (an equivalent combination of education and experience may be considered).
• Demonstrated proficiency in following scientific arguments, well‑established understanding of scientific data and regulations as they relate to drugs and/or biologics.
• Direct experience in US drug development and regulatory submissions supporting investigational and marketing application submissions and lifecycle maintenance activities.
• Experience successfully supporting health authority submissions, clinical trials and critical projects while maintaining agreed timelines.
• Demonstrated experience in Regulatory project management and a clear…