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Lundbeck Seattle BioPharmaceuticals
Associate Director, Regulatory Affairs CMC
Requisition ID: 1506
Location: Bothell, Washington
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with sites worldwide including in Bothell, Washington, Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.
In October 2019, Lundbeck acquired Alder Biopharmaceuticals, now known as Lundbeck Seattle BioPharmaceuticals (Lu-SBP). The Lu-SBP site is responsible for antibody development and biologics manufacturing in collaboration with the global Lundbeck CMC Biologics organization.
SUMMARY
The responsibilities of this position will focus on the generation and implementation of regulatory CMC strategies for Lundbeck Seattle BioPharmaceutical commercial and development programs. This includes responsibility for leading regulatory CMC strategy development; preparation and submission of regulatory documentation to health authorities, and regulatory impact assessment of product lifecycle changes.
ESSENTIAL FUNCTIONS
- Serving as the Regulatory Affairs representative on project teams and assuring the progress of projects by providing sound regulatory guidance and feedback to the respective project team(s)
- Developing and implementing global regulatory filing strategies for INDs/CTAs and marketing authorizations in collaboration with CMC and regulatory teams, including independent analysis of possible scenarios
- Proactively addressing potential critical issues and developing solution strategy with relevant stakeholders
- Evaluating change requests and working with stakeholders for optimal solutions
- Leading teams for efficient preparation, review, and submission of regulatory filings (INDs/CTXs, BLAs/MAAs) to global regulatory agencies, by managing multiple stakeholders within teams
- Developing the strategy for global Health authority meetings, leading preparation of related meeting requests and briefing documents, and participating in meetings
- Reviewing and providing independent guidance on regulatory-related documents (CMC documentation)
- Ensuring compliance with ICH and local regulatory requirements
- Ensuring product-related regulatory strategies are implemented in accordance with global regulations, global product development and commercialization strategies
- Regulatory liaison to external CMO’s supporting Regulatory Affairs activities
- Informing teams and Corporate staff of new regulations and emerging governmental regulatory developments worldwide, and providing assessment of their potential impact
REQUIRED EDUCATION, EXPERIENCE and SKILLS
- Accredited Bachelor’s degree
- 5+ years working in Regulatory Affairs CMC in the pharmaceutical/biotechnology industry
- 8+ years working with biological products
- Extensive knowledge of CMC regulatory requirements for all phases of clinical development including experience with filing INDs for biological products
- Demonstrated success in BLA filing, approval, and lifecycle management
- Demonstrated ability to proactively and effectively influence peers, external colleagues, and across all levels of management
- Results oriented and collaborative; working independently and cross functionally within a matrix team environment
- Possess strong written and oral communication skills
PREFERRED EDUCATION, EXPERIENCE and SKILLS
- BS/BA Degree in a scientific discipline preferred
- Global regulatory CMC experience preferred/
- Combination product (drug/device) experience preferred
- Working knowledge of global CMC regulations, guidelines and practices
- Experience with non-US clinical development and clinical trial application practices
TRAVEL
- Willingness/Ability to travel up to 10% domestically. International travel may be required.
Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
RESOURCES
APPLY:
Lundbeck Seattle BioPharmaceuticals
Reference Job Code: 1506
Lundbeck Seattle BioPharmaceuticals is an Equal Opportunity Employer
Submitted: 12/16/2020
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