Senior Manager, Regulatory Strategy

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Senior Manager, Regulatory Strategy at Lundbeck focusing on regulatory strategies for drug development. Ensuring compliance and managing FDA submission activities for pharmaceutical products.

Posted 5/29/2026full-timeDeerfield • Illinois • 🇺🇸 United StatesSenior💰 $165,000 - $185,000 per yearWebsite

About the role

Key responsibilities & impact

supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological 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
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
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

Requirements

What you’ll need

Accredited Bachelor’s Degree
7+ years within 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

Benefits

Comp & perks

flexible paid time off (PTO)
health benefits to include Medical, Dental and Vision
company match 401k
eligibility for a 15% bonus target based on company and individual performance
eligibility to participate in the company’s long-term incentive plan

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

US Regulatory Affairsregulatory submissionsFDA regulationsdrug developmentbiologicsscientific data analysisregulatory risk identificationnegotiationregulatory strategy developmentlifecycle maintenance activities

Soft Skills

attention to detailorganizational skillsmultitaskingcommunication skillsproblem-solvingindependenceteam collaborationarticulation of regulatory positionscross-functional teamworkpositive communication

Certifications

Bachelor’s Degree