Director US Regulatory Strategy

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!

SUMMARY:

The Director, US Regulatory Affairs Strategy, oversees the implementation of regulatory strategies to ensure the successful development, approval, and lifecycle management of assigned drug and biological products (global products as well as US only products). Provides direct oversight and coordination for US based strategists. Directs a cross functional team to ensure that regional requirements and expectations are achieved in an optimal and compliant manner.

ESSENTIAL FUNCTIONS:

• Serves as US and/or global product registration leader for US products, influencing cross-functional development teams and governance.
• Oversees assembly and creation of documentation to support investigational and marketed product registration packages for the US FDA.
• Liaises with FDA as needed for all aspects pertaining to drug development, approval, and post-approval activities.
• Provides high-level RA advice and identifies regulatory requirements for clinical studies and marketing approval in US.
• Serves as primary regulatory contact for alliance product brands, as assigned, including managing cross-functional and multi-leveled governance and alignment meetings.
• Assesses scientific data for registration purposed against regulatory requirements.
• Maintains awareness of global regulatory legislation and assess its impact on business and Lundbeck product development programs.
• Trains, develops, and manages an effective regulatory affairs cross-functional team on a dotted-line basis (CMC, Regulatory Operations, US Labeling, Promotion Compliance & Scientific Messaging, and International regulatory).

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

• Accredited Bachelor’s Degree
• 10+ years experience within a pharmaceutical, medical device, and/or biotech industry, with 7+ years’ experience in Regulatory Affairs
• Experience with supporting both small molecule and biological products and ensuring regulatory compliance
• Regulatory management experience
• Demonstrated and successful experience with face to face, hybrid, and/or virtual FDA interactions.
• Ability to lead and work in cross-functional, matrixed, hybrid and multinational teams.
• Demonstrated team leadership and motivation of staff to successfully execute regulatory strategies.
• Demonstrated record of investigational and marketing application compliant management and approvals.
• Proven ability to navigate complex compliance and regulatory strategies.
• Seeker of innovative and creative solutions that comply with regulation but are also sound from a business and scientific perspective.
• Provider of contingencies and alternate approaches to cross functional leadership and alliances.
• Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory and systems problems.
• Ability to influence regulatory agency management at all levels to support regulatory needs.
• Highly proficient in communicating strategic and tactical issues to cross functional management.
• Effectively able to multi-task within assigned deadlines.
• Excellent written and oral communication skills

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• Accredited Bachelor’s Degree in life sciences
• Masters. Doctorate Degree or MBA, other professional certifications.
• FDA experience
• Exposure to international regulatory affairs, including participation in submissions to ex-US authorities

TRAVEL:

• Willingness/Ability to travel up to 20% domestically, and international travel may be required.

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $200 ,000 - $230,000and eligibility for a 25% bonus target based on company and individual performance , and eligibility to participate in the company’s long-term incentive plan. B enefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis. #LI-LM1

Why Lundbeck

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site .

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site .

Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify .