Senior regulatory affairs manager

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 at [email protected] 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.