Director US Regulatory Strategy

Lundbeck•Deerfield, IL

2d•$200,000 - $230,000•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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).