Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!
This position is a remote work opportunity
Summary
Responsible for providing regulatory strategic support for global regulatory activities for innovative biologics throughout the lifecycle of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations.
Essential Functions
Serves as regulatory CMC representative on development and marketed product teams.
Responsible for advising teams on regulatory authority expectations and guidelines and ensure the CMC regulatory strategy is in alignment with the global strategy and with the Target Product Profile.
Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of initial marketing applications, supplements/variations, and other submissions which present CMC information.
Maintains an in-depth level of understanding of the company's compounds, their characteristics, manufacturing aspects and specifications/analytical methods
Responsible for the timely completion of well-organized, scientifically sound regulatory CMC submissions, to include DMFs, INDs, CTAs, NDAs, BLAs, MAAs, IDEs, PMAs, etc. and required amendments. Hands-on participation in submission preparation is expected.
Coordinate preparation and review technical reports and CMC sections of global submissions to support clinical investigation and marketing applications.
Ensure compliance with regulatory requirements, strategies, and commitments, which may require partnerships with CRO's or others who work on the company's behalf.
Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
Support CMC QA functions, e.g deviations, general GMP/regulatory mixed topics.
Maintain knowledge of global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate. Maintains an advanced level of understanding and awareness of existing and forthcoming legislation to advise project teams accordingly
Required Education, Experience, and Skills.
Accredited Bachelor Degree
8+ years experience in the Pharmaceutical Industry with direct experience with small molecule/biologic technical functions.
5+ years' experience in Regulatory CMC with progressive experience in supporting global programs from pre-approval or post-marketing.
Capability to interact with CMC technical experts regarding process development and analytical issues.
Demonstrated success in global submission filing, approval, and lifecycle management
Demonstrated ability to proactively and effectively influence peers, external colleagues, and across all levels of management
The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation
Preferred Education, Experience, and Skills
Bachelor of Science or Arts Degree; life science related degree is preferred
Minimum of three (3) years People Management/ Leadership experience with proven track record of developing talent (preferred)
Travel Requirements
Willingness/Ability to travel up to 30-40 % domestic and international travel will be required.
The range displayed is specifically for those potential hires who will work or reside in the state of New York, Colorado and Connecticut, if selected for this role, and may vary based on various factors such as the candidate's qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $175,000 - $225,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Additional benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision and a company match 401k. Additional benefits information can be found on our career site.
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Why Lundbeck
Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time?
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.
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.
