Senior Regulatory Affairs Manager SRAM 1014 AS#01

Boston, NH - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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.
Bachelors 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 or 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.

Required Experience:

Manager

Job Title: Senior Regulatory Affairs Manager Location: Remote Duration: 12 MonthsPay Rate: $35/hr on W2Position OverviewWe are seeking an experienced and highly motivated Senior Regulatory Affairs Manager to lead global regulatory operations compliance and information management initiatives within a...