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!

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

The Director, US Regulatory Affairs Strategy, oversees the implementation of regulatory strategies to ensure the successful development and approval of assigned drug and biological products for the United States (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 marketing 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 R&D experience within a pharmaceutical 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 (direct or indirect)

• 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
• Strong Preference to be based in Deerfield, IL Office

TRAVEL:

• Willingness/Ability to travel up to 20% domestically, and international travel may be required.
• If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business

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