Location: Remote
Duration: 6+ months
We are seeking an experienced Senior Regulatory Affairs Manager to lead global regulatory operations, information management, and compliance initiatives in a pharmaceutical setting. The role involves overseeing regulatory information management (RIM), CMC compliance, cross-functional projects, and team leadership to ensure successful regulatory submissions and adherence to global standards.
Lead and manage global regulatory teams handling submission management, regulatory information management, and CMC compliance across multiple markets.
Oversee large-scale RIM implementations, including data migration, validation, UAT, and change management.
Manage regulatory projects such as marketing authorization transfers, dossier updates, and legal entity rationalization across regions.
Drive continuous improvement initiatives and process optimization using Lean Six Sigma methodologies.
Collaborate with cross-functional teams (CMC, quality, clinical, legal) to ensure regulatory compliance and timely submissions.
Develop and maintain regulatory strategies aligned with global regulatory requirements and corporate goals.
Lead training and communications for regulatory systems, processes, and data standards.
Act as liaison between internal stakeholders, clients, and regulatory agencies for effective project execution.
Minimum 10+ years of regulatory affairs experience in the pharmaceutical industry with leadership responsibilities.
Proven expertise in regulatory information management systems (e.g., Veeva Vault, Liquent Insight, Global Submission Viewer) and submission lifecycle management.
Strong knowledge of CMC regulatory requirements, dossier preparation, and post-approval changes across global markets.
Experience managing large, cross-functional, global projects and teams.
Demonstrated success in data migration, UAT, and change management activities.
Familiarity with marketing authorization transfers, legal entity rationalization, and compliance programs.
Excellent project management, strategic planning, and business analysis skills.
Lean Six Sigma Green Belt preferred.
Strong technical writing, communication, and stakeholder management skills.
Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degrees or regulatory certifications a plus.
Experience working with top-tier pharmaceutical companies.
Knowledge of regulatory submission requirements for various dossier formats (centralized, decentralized, national).
Ability to operate in a matrix environment and lead cross-functional teams across geographies.
For more details reach at vgill@navitassols.com/516-862-1203
About Navitas Healthcare, LLC certified WBENC and one of the fastest-growing healthcare staffing firms in the US providing Medical, Clinical and Non-Clinical services to numerous hospitals. We offer the most competitive pay for every position we cater. We understand this is a partnership. You will not be blindsided and your salary will be discussed upfront.