Senior Manager Regulatory Strategy

Chapter 13 Trustee Middle District of Alabama

Bensenville, Northern (IL, KY)

Hybrid

USD 120,000 - 180,000

Full time

14 days+

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Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

401k

Job summary

Lundbeck is seeking a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for innovative neuroscience therapies.

You will shape development and registration plans, drive submissions (INDs, NDAs, sNDAs), and provide strategic guidance to cross‑functional teams. You will interface with FDA and other health authorities, assess regulatory risks, and ensure compliance with evolving requirements.

Qualifications

RAC certification preferred.
JD or advanced degree in law/compliance a plus.
CHC certification a plus.
PMP certification a plus.

Responsibilities

Lead U.S. and global regulatory strategy for neuroscience products across development and lifecycle.
Own planning, preparation, and submission of INDs, NDAs, sNDA, and other filings.
Serve as primary regulatory point of contact to cross-functional teams (R&D, clinical, safety, commercial, legal).
Plan and lead interactions and meetings with FDA and other health authorities.
Monitor evolving regulatory requirements and translate into internal strategies.
Identify, communicate, and mitigate regulatory risks for pipeline and marketed products.
Ensure regulatory and promotional compliance in partnership with Legal & Regulatory Compliance.
Contribute to labeling strategy and lifecycle management.
Mentor junior regulatory staff and support best-practice processes.

Skills

Regulatory strategy

IND/NDAs

Cross-functional leadership

FDA interactions

Global regulatory affairs

Education

Regulatory Affairs Certification (RAC)

JD or advanced degree in law/compliance

Healthcare Compliance Certification (CHC)

Project management certification (PMP)

Job description

Lundbeck is seeking a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for innovative neuroscience therapies. In this Legal & Regulatory Compliance role, you will shape development and registration plans, drive submissions (INDs, NDAs, sNDAs), and provide strategic guidance to cross‑functional teams. You will interface with FDA and other health authorities, assess regulatory risks, and ensure compliance with evolving requirements. At Lundbeck, you’ll work in a collaborative, patient‑focused culture with strong support for learning, development, and career growth in a mission‑driven environment.

Responsibilities

Lead U.S. and global regulatory strategy for assigned neuroscience products across development and commercialization lifecycle
Own planning, preparation, and submission of INDs, NDAs, sNDAs and other regulatory filings
Serve as primary regulatory point of contact to cross-functional teams (R&D, clinical, safety, commercial, legal)
Plan and lead interactions and meetings with FDA and other health authorities
Monitor and interpret evolving regulatory requirements and guidances and translate into internal strategies
Identify, communicate, and mitigate regulatory risks for pipeline and marketed products
Ensure regulatory and promotional compliance in partnership with Legal & Regulatory Compliance
Contribute to labeling strategy, negotiation, and lifecycle management
Mentor junior regulatory staff and support best-practice processes and tools
Support due diligence and business development activities from a regulatory perspective
Regulatory strategy development
Knowledge of FDA regulations and guidance
Global regulatory affairs (ICH, EMA) knowledge
Regulatory submissions (IND, NDA, sNDA, CTA)
Labeling and promotion regulatory review
Risk assessment and mitigation
Cross-functional leadership and collaboration
Project and portfolio management
Scientific and clinical data interpretation
Health authority meeting preparation and negotiation