Manager Global Regulatory Affairs

Net2Source (N2S); New Jersey; On-site; USD 120,000 - 190,000; Full time

Job summary

Net2Source (N2S) seeks a Global Regulatory CMC Manager to lead global CMC regulatory strategy and submissions across diverse modalities. The role requires collaboration with Regulatory, Clinical, Manufacturing, and Quality to ensure compliant submissions and lifecycle management.

The position emphasizes cross-functional leadership, expert regulatory knowledge across FDA/EMA/ICH, and ongoing readiness for health authority interactions. Ideal for senior professionals with extensive CMC experience.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 10–15 years in pharma/biotech with regulatory CMC exposure.
• 5–7+ years supporting global regulatory submissions and lifecycle activities.
• Experience with FDA, EMA, ICH guidelines and health authority interactions.

Responsibilities

• Contribute to development and execution of global CMC regulatory strategies.
• Prepare and submit global regulatory dossiers (INDs, CTAs, NDAs/BLAs, MAAs).
• Maintain alignment with FDA/EMA/ICH guidelines and post-approval changes.
• Manage cross-functional teams and regulatory documentation.
• Support regulatory audits, inspections, and agency interactions.
• Provide lifecycle management for development and commercial products.

Skills

CMC regulatory knowledge

Regulatory submissions

Cross-functional leadership

Regulatory strategy

Problem-solving

Education

Bachelor's degree in a scientific discipline

Master's or PhD (preferred)

Tools

eQRMS

Infinity

Veeva/Verity

Job description

Job Title: Global Regulatory CMC Manager

Job Description

Position Summary

The Global Regulatory CMC Senior Consultant is responsible for supporting the development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies across a diverse portfolio, including small molecules, biologics, and advanced therapies (e.g., cell and gene therapy). This role collaborates cross-functionally to ensure timely, high-quality regulatory submissions and compliance with global health authority requirements throughout the product lifecycle.

Key Responsibilities

Regulatory Strategy & Submissions

• Contribute to the development and implementation of global CMC regulatory strategies aligned with clinical and commercial objectives
• Support preparation and submission of global regulatory dossiers, including:
• INDs / CTAs
• NDAs / BLAs
• MAAs
• Health authority briefing packages and scientific advice documents
• Author, review, and manage CMC sections of regulatory submissions, ensuring accuracy, completeness, and compliance with regional requirements

Regulatory Documentation & Compliance

• Prepare and review CMC documentation, including responses to health authority questions, post-approval variations, and lifecycle management submissions
• Ensure alignment of regulatory documentation with current FDA, EMA, ICH, and other global regulatory guidelines
• Maintain inspection readiness and support regulatory audits/inspections as needed

Change Management & Lifecycle Support

• Evaluate and provide regulatory impact assessments for CMC change controls within global quality systems (e.g., eQRMS, Infinity, Veeva/Verity)
• Support implementation of post-approval changes, ensuring compliance with regional reporting requirements
• Participate in lifecycle management planning for both development and commercial products

Cross-Functional Leadership

• Serve as the Regulatory CMC representative on cross-functional development and commercial teams
• Collaborate with functions including Manufacturing, Quality, Analytical Development, Supply Chain, and Clinical/Regulatory teams
• Facilitate document review meetings and drive alignment across stakeholders

Health Authority Interactions

• Support preparation for and participation in global regulatory agency interactions (e.g., FDA, EMA, PMDA), including meeting requests, briefing books, and follow-up responses
• Ensure clear communication of regulatory expectations and commitments across internal stakeholders

Project Management & Execution

• Manage multiple projects and timelines to ensure delivery of high-quality regulatory outputs
• Proactively identify risks, propose mitigation strategies, and drive resolution of complex CMC regulatory issues
• Maintain current knowledge of evolving global regulatory requirements, industry trends, and best practices in CMC
• Contribute to process improvements and regulatory excellence initiatives

Qualifications

• Bachelor’s degree (BS/BA) in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Chemical Engineering, or related field); Master’s or PhD strongly preferred
• 10–15 years of experience in the pharmaceutical/biotechnology industry
• 5–7+ years of Regulatory CMC experience supporting clinical and/or commercial programs
• Demonstrated experience supporting global regulatory submissions and lifecycle management activities

Technical Expertise

• Strong knowledge of CMC regulatory requirements across multiple regions (FDA, EMA, ICH guidelines)
• Hands-on experience with:
• INDs, CTAs, NDAs, BLAs, MAAs
• Variations, supplements, and health authority responses
• Briefing documents and regulatory meeting preparation
• Understanding of drug development lifecycle, including early development through commercialization and post-approval changes

Regulatory Strategy & Problem-Solving

• Ability to contribute to CMC regulatory strategy development
• Strong analytical skills with a solution-oriented mindset
• Ability to assess regulatory risk and recommend compliant, pragmatic solutions

Project & Change Management

• Experience managing multiple deadlines and priorities in a fast-paced environment
• Familiarity with electronic quality and change management systems (e.g., eQRMS, Infinity, Verity/Veeva)
• Ability to support planning and prioritization of team deliverables
• Proven ability to work effectively in cross-functional global teams
• Excellent written and verbal communication skills, with the ability to translate complex technical information for diverse audiences
• Strong interpersonal skills and ability to influence without authority

Leadership & Growth

• Demonstrated initiative and accountability, with appropriate level of independence
• Ability to mentor junior staff and contribute to team development

Preferred Qualifications

• Experience with biologics and/or advanced therapies (cell & gene therapy)
• Exposure to global regulatory interactions and agency communications
• Experience supporting both clinical and commercial-stage products