Job Title: Senior Regulatory Affairs Manager
Location: Remote
Duration: 12 Months
Pay Rate: $35/hr on W2
We are seeking an experienced and highly motivated Senior Regulatory Affairs Manager to lead global regulatory operations, compliance, and information management initiatives within a dynamic pharmaceutical environment. This role requires deep expertise in Regulatory Information Management (RIM), CMC compliance, and global submission management, with a proven ability to manage large-scale regulatory projects and cross-functional teams across multiple markets.
Lead and oversee global regulatory affairs teams responsible for submission management, regulatory information management, and CMC compliance across various therapeutic areas.
Manage large-scale regulatory information management system implementations, including data migration, validation, user acceptance testing (UAT), and change management.
Oversee regulatory projects such as marketing authorization transfers, dossier updates, and legal entity rationalization across global markets.
Drive process improvement and operational efficiency using Lean Six Sigma methodologies.
Collaborate with cross-functional stakeholders (CMC, quality, clinical, legal, etc.) to ensure regulatory compliance and timely project delivery.
Develop and maintain global regulatory strategies and compliance plans aligned with corporate and regional requirements.
Lead training and communication efforts related to regulatory systems, processes, and data standards.
Serve as a key liaison between internal stakeholders, clients, and regulatory agencies to support effective communication and project execution.
10+ years of experience in Regulatory Affairs within the pharmaceutical industry, with increasing leadership responsibility.
Proven expertise with Regulatory Information Management (RIM) systems such as Veeva Vault, Liquent Insight, or Global Submission Viewer.
Strong understanding of CMC regulatory requirements, dossier preparation, and post-approval changes across multiple global markets.
Experience leading global, cross-functional teams and managing complex regulatory projects.
Hands-on experience in data migration, UAT, and change management within regulatory systems.
Familiarity with marketing authorization transfers, legal entity rationalization, and compliance programs.
Strong project management, strategic planning, and business analysis capabilities.
Lean Six Sigma Green Belt certification preferred.
Exceptional communication, technical writing, and stakeholder management skills.
Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline (advanced degrees or Regulatory Affairs certifications preferred).
Experience working with Top 5 or Top 20 global pharmaceutical organizations.
Knowledge of global submission procedures (centralized, decentralized, national, and mutual recognition).
Ability to operate effectively in a matrixed, global team environment.
For more details reach at vgill@navitassols.com or Call / Text at 516-862-1203.
About Navitas Partners, LLC: It is a certified WBENC and one of the fastest-growing Technical / IT staffing firms in the US providing services to numerous clients. We offer the most competitive pay for every position. We understand this is a partnership. You will not be blindsided and your salary will be discussed upfront.