Senior Manager 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 Opportunity - Open to candidates anywhere in the greater United States. Preferably East Coast or Midwest.

SUMMARY:

The Senior Manager, Regulatory Strategy (US RA): supports 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); participates on global cross-functional teams ensuring that US requirements and expectations are achieved in an optimal and compliant manner; ensures compliance with regulatory requirements and corporate standards; maintains candid and positive communications with cross functional partners and operational support.

ESSENTIAL FUNCTIONS:

• Provides regulatory review of product documentation intended for regulatory submissions for accuracy and compliance with FDA regulations. Manages, reviews and represents US regulatory perspective at Regulatory Affairs Focus Team (RAFT) meetings. Identifies risk, problem-solves, and offers solutions. Manages/supports related FDA submission activities in compliance with current regulations and guidances.
• Working with US regulatory management and the Global Regulatory Lead, serves as US subject matter expert to support strategy development and execution for assigned products.
• Acts as FDA contact for assigned products. Liaises with regulatory authorities for all drug development and approval aspects.
• Manages the processing of regulatory submissions with Strategy leadership and operational support; ensures submissions are prepared in compliance with regulatory requirements and guidance documents; ensures that appropriate review and approval is obtained.
• Monitors the external regulatory climate to inform internal customers of potential impact on long-term objectives.
• Assists or leads improvement efforts supporting necessary compliance enhancements and departmental efficiencies.
• Manages assembly and creation of documentation supporting investigational and new drug application/biologic license application for the US FDA throughout the product's lifecycle.
• Provides high-level RA advice and identifies US regulatory requirements for clinical studies and marketing.
• Assesses scientific data for proposed registration and labeling against current FDA guidance's, regulations, and precedence.
• Facilitates policy and development of standard interpretation of US regulations.
• Maintains awareness of US regulatory legislation and assess its impact on business and Lundbeck product development programs.
• Completes internal and external training on departmental initiatives and for compliance purposes.

• Accredited Bachelor's Degree
• 7+ years within the pharmaceutical and/or biotech industry or for a consulting company supporting the pharmaceutical and / or biotech industry
• 5+ years direct experience in US Regulatory Affairs
• Direct experience in US drug development and regulatory submissions supporting investigational and marketing application submissions and lifecycle maintenance activities.
• Demonstrated proficiency in following scientific arguments, well-established understanding of scientific data and regulations as they relate to drugs and/or biologics
• Experience in identifying regulatory risk and negotiating/resolving differences
• Attention to detail and strong organizational skills with the ability to meet multiple deadlines and multitask within assigned projects
• Demonstrated ability to work in a multi-disciplinary, matrixed and multinational team
• Excellent oral and written communication skills across all levels of the organization, including ability to articulate regulatory positions
• Ability to successfully prepare and execute regulatory strategies along with providing contingencies and alternate approaches
• Ability to work independently
• High proficiency in MS Word, MS Excel and Adobe Acrobat and regulatory electronic document management systems

• The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation

• Accredited Bachelor's Degree in Science, Chemistry, or Pharmacy
• Advanced Degree in Science, Chemistry, Pharmacy or related subject study/experience
• Experience in Biologic Development
• Familiarity with Chemistry, Manufacturing and Controls requirements

• Willingness/Ability to travel ~5% domestically to business meetings and learning experiences.