Senior Manager, Regulatory Strategy

by hrukblogger

Senior Manager, Regulatory Strategy

SUMMARY

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, Alzheimers disease and Parkinsons 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 isnt 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 Senior Manager, Regulatory Strategy: works independently with minimal management oversight on novel regulatory strategy development and IND and NDA registrations for multiple drug development programs; serves as the regulatory strategist in development and implementation of regulatory strategies to support drug development programs; and works with cross functional teams and global RA counterparts to ensure regional requirements and commercial expectations are achieved while ensuring compliance with applicable regulations.

ESSENTIAL FUNCTIONS
* US Regulatory Lead for multiple drug development programs, working with Global Regulatory Lead to provide US regulatory strategic and operational input to cross functional development teams
* Key member of marketed product team developing and implementing the regulatory strategies, such as developing life-cycle product development, PRM compliance, CMC changes, label revision, and safety reports
* Coordinates meetings between FDA and Lundbeck by drafting meeting requests, reviewing briefing materials, and assisting on the formal FDA meeting preparations
* Serves as Lundbeck US Regulatory representative to support Lundbecks alliance projects, including regulatory strategy development, contributions to submission documentation, and to coordination of feedback from internal subject matter experts and commercial stakeholders
* Manages compilation of regulatory documentation for responsible INDs or NDA. Ensures assigned US drug applications are compliant with all current regulations by reviewing all Regulatory dossiers for completeness and accuracy prior to submission.
* Liaises with FDA to coordinate the correspondences between the Agency and Lundbeck on new clinical study proposals and Life Cycle Management initiatives
* Maintains awareness of global Regulatory legislation and assess its impact on business and Lundbeck product development programs
* Works independently with minimal oversight from Senior RA management to develop creative solutions to unusually complicated Regulatory and systems problems

REQUIRED EDUCATION, EXPERIENCE and SKILLS:
* Accredited Masters degree or higher
* 6+ years of Pharmaceutical Industry experience
* 4+ years Regulatory Affairs experience
* Experience as the direct FDA liaison for marketed product and/or development programs

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
* Additional degree(s) or certifications
* NDA and IND filing experience

TRAVEL
* Willingness/Ability to travel up to 10% domestically. International travel may be required on occasion