Manager Regulatory Affairs Operations
The Manager, Regulatory Affairs Operations provides technical and operational leadership, and strategic partnership for regulatory publishing and submission activities to global Health Authorities (e.g., FDA, Health Canada, and international agencies). This role is accountable for ensuring high-quality, compliant, and timely regulatory submissions across the product lifecycle, while also driving process optimization, technical standards, and capability development within Regulatory Affairs Operations.
In addition to hands-on oversight of complex submissions, the Manager plays a key role, providing technical guidance and upskilling to cross-functional partners and vendors, and shaping the globalization and modernization of regulatory publishing processes in alignment with evolving Health Authority expectations and internal digital strategies.
ESSENTIAL FUNCTIONS:
Regulatory Submission & Technical Oversight
- Provides technical oversight and quality accountability for IND, NDA, BLA, and DMF original and lifecycle submissions in eCTD format, ensuring compliance with global Health Authority requirements and internal standards.
- Oversees and reviews critical publishing components (e.g., eCTD structure, metadata, hyperlinks, lifecycle management, validation results) to ensure submission readiness and inspection defensibility.
- Serves as a technical escalation point for complex publishing issues, including direct interaction with Health Authorities to assess submission troubleshooting and issue resolution.
- Ensures consistent application of regulatory publishing standards across programs, products, and regions.
Process Ownership & Modernization
- Contributes to the development, implementation, and continuous improvement of regulatory publishing processes, SOPs, work instructions, and technical standards.
- Provides subject matter leadership for the globalization of publishing practices, supporting harmonized approaches across regions and affiliates.
- Actively supports modernization and digital enablement initiatives, including adoption, validation, and optimization of publishing tools, systems, and technologies.
- Participates in system validation, upgrades, and implementation efforts, ensuring regulatory and inspection readiness.
Training, Capability Building & Cross-Functional Enablement
- Under the direction of Assoc. Dir, supports the development and delivers role-based training for Regulatory Affairs Operations staff on publishing standards, tools, lifecycle management, and Health Authority expectations.
- Responsible to develop and deliver training for cross-functional SMEs (e.g., Regulatory Affairs, CMC, Clinical, Biostats, Labeling) on technical data and document readiness regulatory requirements to support high-quality submissions.
- Acts as a technical mentor and coach to the Regulatory Publishing team, supporting skill development and consistency in publishing practices.
Leadership & Operational Support
- Supports the functional management in workload planning, prioritization, and resource allocation for regulatory submissions.
- Serves as a liaison to global counterparts in publishing and operations to drive organizational effectiveness.
- Provides guidance to internal staff and external vendors/contractors involved in publishing activities.
- May participate in submission task forces, kickoff meetings, inspections, audits, and special projects as a Regulatory Operations representative.
- Contributes to departmental metrics, compliance monitoring, and inspection preparedness activities.
REQUIRED EDUCATION AND SKILLS:
- Accredited bachelor's degree
- 5+ years of experience in Regulatory Affairs, Regulatory Operations, or R&D Submission Support within the pharmaceutical industry
- 5+ years of direct, hands-on experience with eCTD publishing software across multiple regions, including the US, EU, Canada, and Rest of World (ROW)
- Expert-level proficiency with MS Office Suite and Adobe Acrobat, including regulatory publishing tools and plugins such as ISI Toolbox and SmartDesk
- Demonstrated proficiency with document management systems (EDMS), eCTD validators, and XML/SPLs
- Hands-on experience submitting SPLs, datasets (SEND, ADAM), and related regulatory submission components
- Proven ability to manage shifting priorities and successfully complete multiple tasks with overlapping deadlines
- Strong attention to detail and excellent organizational skills
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Project/Submission Readiness Management skills
- Cross Functional Team participation
- Experience using Docubridge submission publishing system
- Experience with Veeva systems (i.e. eTMF, PromoMats, RIM)
- Strong Preference to be based in Deerfield, IL Office
TRAVEL:
- Willingness/Ability to travel up to 10% domestically. International travel may be required.
About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
