Director, US Regulatory Affairs Strategy

Job Description

Director US Regulatory Strategy | Lundbeck

The Tone:
This is a full-time role at Lundbeck, a global biopharmaceutical company dedicated exclusively to brain health. With over 70 years in neuroscience, Lundbeck focuses on improving the lives of individuals with neurological and psychiatric diseases. This Director role is crucial for overseeing regulatory strategies, directly contributing to the successful development, approval, and lifecycle management of important drug and biological products for the US market. Join a team inspired to advance brain health and transform lives through complex and meaningful challenges.

The TL;DR
• Role: Full Time
• Type: Full-time
• Location: US-based, with up to 20% domestic and potential international travel
• Pay: $200000–$230000 yearly
• Team: Leads US strategists and a dotted-line cross-functional regulatory team
• Mission: Oversees the implementation of regulatory strategies to ensure the successful development, approval, and lifecycle management of assigned drug and biological products.

What You’ll Actually Do
• Oversee US regulatory strategy implementation for assigned drug and biological products, spanning their development, approval, and lifecycle management.
• Serve as the US and/or global product registration leader for US products, actively influencing cross-functional development teams and governance.
• Provide direct oversight and coordination for US-based strategists, and train, develop, and manage a dotted-line cross-functional regulatory team.
• Liaise directly with the FDA for all aspects pertaining to drug development, approval, and post-approval activities, while assessing scientific data for registration purposes against regulatory requirements.
• Offer high-level regulatory affairs advice and identify requirements for clinical studies and marketing approval in the US, and act as the primary regulatory contact for assigned alliance product brands.

The Must-Haves
• Background: Accredited Bachelor’s Degree. Director-level experience in US Regulatory Affairs strategy within the pharmaceutical, medical device, and/or biotech industry, specifically involving drug and biological products.
• Experience: 10+ years in the pharmaceutical, medical device, and/or biotech industry, with at least 7 years focused on Regulatory Affairs. Demonstrated regulatory management experience, including successful face-to-face, hybrid, and/or virtual interactions with the FDA. Proven record of compliant investigational and marketing application management and approvals.
• Skills: Ability to lead and motivate staff within cross-functional, matrixed, hybrid, and multinational teams. Proven ability to navigate complex compliance and regulatory strategies, offering innovative and sound business/scientific solutions. Highly proficient in communicating strategic and tactical issues to cross-functional leadership and alliances, with excellent written and oral communication skills.
• Bonus: Master’s, Doctorate Degree or MBA, or other professional certifications. Prior FDA experience. Exposure to international regulatory affairs, including participation in submissions to ex-US authorities.