Senior Regulatory Affairs Manager

2 days ago

Boston, Massachusetts, United States NavitsPartners Full time $140,000 - $200,000 per year

Job Title: Senior Regulatory Affairs Manager

Location: Remote

Duration: 12 Months

Pay Rate: $35/hr on W2

Position Overview

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.

Key Responsibilities
  • 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.
Qualifications
  • 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).
Preferred Skills
  • 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 ator Call / Text at .

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.

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