Vice President, US Regulatory Affairs
701 - Regulatory
Vice President, US Regulatory Affairs
No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease.
For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them.
The VP, US Regulatory Affairs leads both the strategic and operational aspects of Regulatory Affairs objectives for commercial products, life cycle management initiatives and acquisitions including global FDA regulatory strategy, regulatory submissions, and interaction with regulatory authorities. This role is also responsible for managing existing INDs and initiating INDs for pipeline products, subsequent FDA filings, as well as clinical trial applications and all other documentation to be compliant with all regulatory requirements. The successful candidate is the senior regulatory strategist, and is a member of the US Drug Development Senior Leadership Team as well as other global regulatory leadership and cross-functional work teams.
- Provides regulatory leadership to local and global cross-functional teams through strong collaboration, ensuring perspective/expertise is incorporated in regulatory plans prior to decisions being made to secure FDA approval of new drugs and new indications for existing drugs.
- Directs the global team in developing, implementing and delivering a U.S. regulatory strategy for highly complex products which optimize the balance of time, cost, quality and risk to meet the needs of Lundbeck. Drives regulatory aspects of marketed product life cycle management including critical issue management and major line extensions.
- Presents regulatory strategies to internal governance bodies. Influences internal and external customers as necessary to ensure successful strategy implementation and in support of business marketing goals.
Operations, Quality, Compliance
- Responsible for generating and implementing US operational regulatory practices to support document creation and submission across the company’s development and commercial product portfolio.
- Leads interactions with project team members, consultants, contractors and regulatory authorities to ensure regulatory paths are clearly defined and milestones are met leading to successful filings and approvals.
- Accountable for the timely development and submission of U.S. regulatory documents (e.g., pre-IND and end-of-phase briefing books, INDs, NDA/BLAs, CTAs, MAAs, responses to regulatory queries, IND safety reports, etc.).
- Ensures quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOPs. Creates and implements new SOPs as necessary to maintain regulatory compliance with new drug regulations.
- Provides interpretative analyses of complex regulatory guidance documents, regulations, or directives that impact the company’s products and operations and leads the response respectively.
- Seeks innovative and creative operational solutions that comply with regulations and are sound from business and scientific perspectives.
- Responsible for overall assessment of scientific data for registration purposes against regulatory requirements.
- Provides contingencies and alternate approaches to Senior Management and/or partners to resolve any development program challenges.
- Responsible for management of Regulatory Affairs budget.
- Leads communications ensuring internal global awareness and understanding of current U.S. regulatory legislation. Monitors and communicates development of new guidelines and procedures to assess the impact and ensure compliance for product development programs.
- Leads response on behalf of global Lundbeck to proposed FDA regulatory policies and guidelines.
- Actively manages all liaisons with regulatory authorities as needed for all aspects pertaining to drug development and approval.
- Works closely with Alliance partners to prepare and execute U.S. development programs.
- Provides strong leadership, mentorship, training, development and ensures fit for purpose organizational design to the Regulatory team; enhancing and promoting staff growth and development.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Accredited Advanced degree in a relevant scientific discipline
- 10+ years’ progressive experience in regulatory within the pharmaceutical and/or biotech industry
- Track record of successfully setting regulatory strategy, product registrations, and regulatory filings (e.g. IND, NDA and other similar regulatory filings) with FDA
- US regulatory experience
- Demonstrated leadership and motivation of staff to successfully execute regulatory strategies.
- Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory and systems challenges
- Demonstrated ability to influence management, locally and globally, at all levels to support regulatory strategic and operational department needs.
- Highly proficient in communicating and presenting strategic and tactical issues to all levels, including top management and regulatory agencies
- Ability to lead and work in local and global cross-functional teams
- Effectively able to multi-task within assigned deadlines
- Previous experience leading teams with responsibility for performance management and reward planning
PREFERRED EDUCATION, EXPERIENCE and SKILLS:
- 15+ years R&D, medical or scientific experience within the pharmaceutical and/or biotech industry.
- Advanced degree (e.g. PhD / Pharm D / MD)
- CNS experience
- Experience working with FDA at the policy level (e.g. influencing direction of regulatory guidance)
- Demonstrated ability to lead FDA strategy in global organization
- Due diligence / M&A experience
- Willingness/Ability to travel up to 25% domestically. International travel is required.