Director Regulatory Affairs CMC

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? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

Remote Opportunity - Open to candidates within the United States, preferably on the East Coast

Summary

Responsible for providing regulatory strategic support for global regulatory activities for innovative biologics throughout thelifecycle of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support andguidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatorycolleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with thehighest 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 regulatorystrategy is in alignment with the global strategy and with the Target Product Profile.
• Manage interactions with Health Authorities for assigned project(s) to ensure acceptance, rapid review and approval ofinitial 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 aspectsand specifications/analytical methods.
• Responsible for the timely completion of well-organized, scientifically sound regulatory CMC submissions, to includeDMFs, INDs, CTAs, NDAs, BLAs, MAAs, IDEs, PMAs, etc. and required amendments. Hands-on participation in submissionpreparation is expected.
• Coordinate preparation and review technical reports and CMC sections of global submissions to support clinicalinvestigation and marketing applications.
• Ensure compliance with regulatory requirements, strategies, and commitments, which may require partnerships withCRO's or others who work on the company's behalf.
• Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategicregulatory 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, providinginterpretation to internal stakeholders and initiating process improvements as appropriate.
• Maintains an advanced level of understanding and awareness of existing and forthcoming legislation to advise projectteams accordingly.

Required Education, Experience, and Skills

• Accredited bachelor's degree
• Minimum of eight (8) years of experience in the Pharmaceutical, Biotech or Medical Device Industry with direct experience with small molecule/biologic technical functions.
• Minimum of five (5) years of 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.

Preferred Education, Experience, and Skills

• Bachelor of Science or Arts Degree; life science related degree
• Master or PhD of Science
• Combination product (drug/device) experience

Travel Requirements

• Willingness/Ability to travel up to 10 % international travel will be required.

The range displayed is a national range, and if selected for this role, may vary based onvarious factorssuch as the candidate's geographical location, qualifications, skills,competencies,andproficiencyfor the role.Salary Pay Range:$225,000 - $255,000andeligibilityfor a 25%bonustargetbased on company and individual performance, and eligibility toparticipatein the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k.Additional benefits information can be found on oursite.Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

Why Lundbeck

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. 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.