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[Remote] Site Portfolio Optimization & Regulatory Affairs Consultant

Remote · Poland Full-time

Note: The job is a remote job and is open to candidates in USA. Brooksource is seeking an experienced consultant to support life sciences clients through site portfolio optimization and regulatory affairs initiatives. This role focuses on providing strategic guidance and advisory support throughout the project lifecycle, including discovery, solution design, and project delivery.

Responsibilities

  • Participate in client discovery sessions and solution development effort
  • Support proposal creation, project scoping, and statement of work (SOW) development
  • Advise on site consolidation, facility transitions, manufacturing transfers, and portfolio optimization strategies
  • Assess regulatory impacts related to site changes, product registrations, and manufacturer-of-record transitions
  • Identify operational, financial, and compliance risks and recommend mitigation strategies
  • Provide on-demand subject matter expertise to consulting teams and clients as new opportunities arise

Skills

  • Experience in Regulatory Affairs within pharmaceutical, biotech, medical device, or life sciences organizations
  • Expertise supporting site transitions, facility consolidations, manufacturing transfers, or portfolio optimization programs
  • Strong understanding of product registrations, manufacturer-of-record requirements, and global regulatory compliance
  • Experience contributing to project scoping, proposal development, consulting engagements, or SOW creation
  • Ability to operate as both a strategic advisor and hands-on consultant

Benefits

  • Remote, flexible consulting engagement

Company Overview

  • Brooksource is a single source for project and supplemental support through contract employment, contract-to-hire labor employment. It was founded in 2000, and is headquartered in Indianapolis, Indiana, USA, with a workforce of 1001-5000 employees. Its website is http://www.brooksource.com.
  • Company H1B Sponsorship

  • Brooksource has a track record of offering H1B sponsorships, with 9 in 2026, 13 in 2025, 18 in 2024, 11 in 2023, 10 in 2022, 23 in 2021, 20 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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