Director Regulatory Affairs CMC Employer Lundbeck Location Deerfield, IL, US Start date Aug 5, 2026 View more categories View less categories Discipline Regulatory , Regulatory Affairs , Science/R D , CMC Required Education Bachelors Degree Position Type Full time Hotbed BioMidwest , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details 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!

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 Health 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'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:

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 on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role.

Salary Pay Range:

$220,000

• $250,000 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.

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 our site. Applications accepted on an ongoing basis. #LI-LM1 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 . Company Lundbeck is a global biopharmaceutical company specialized in brain diseases. We are dedicated to advancing brain health and transforming lives. To fulfill this purpose, Lundbeck is engaged in the research, development, manufacturing, and commercialization of pharmaceuticals across the world. For more than 70 years, Lundbeck has been at the forefront of neuroscience research. Our commitment is to empower patients to give them the tools and resources they need to understand their disease and its unfolding. Our commitment is to continuously challenge status quo and push our science further to make real differences for patients. Our commitment is to families to bring evidence-based data, visibility and support to their work in managing a chronic disease. Our commitment is to communities to end the stigma, fear, and silence that surrounds brain diseases. Our commitment is to society, to increase access to medicines for the most vulnerable, to act responsibly towards the environment and to behave with respect and integrity in everything we do.

Offices in:

Deerfield, IL

• Lundbeck US Home Office La Jolla, CA
• Lundbeck La Jolla Research Center, Inc. Bothell, WA
• Lundbeck Seattle BioPharmaceuticals, Inc Company info Website https://www.

lundbeck.com/global Phone 224-507-1000 Location 6 Parkway North Deerfield Illinois 60015 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Senior Manager, Global Development Quality Assurance (GCP) United States GLP Vendor Oversight and Quality Assurance Lead King of Prussia, PA Director, Process Safety and Design North Chicago, IL