Manager – CMC Regulatory Affairs (Nonclinical)

JOB PURPOSE

We are seeking an experienced Manager – CMC Regulatory Affairs (Nonclinical) with 10–12 years of hands-on experience supporting global regulatory submissions for biologics, advanced therapies, and/or gene therapy products. The successful candidate will have strong expertise in Nonclinical and CMC regulatory strategy, authoring, reviewing, compiling, and maintaining regulatory submission content, with demonstrated experience supporting US INDs, EU IMPDs, and BLAs. The role requires close collaboration with CMC, Nonclinical, Clinical, Quality, Regulatory, Document Management, and Publishing teams to ensure high-quality, compliant, and timely regulatory submissions.

DUTIES AND RESPONSIBILITIES

• Lead and/or independently support the authoring, reviewing, compiling, and maintenance of Nonclinical and CMC sections for global regulatory submissions.
• Support preparation and submission of US INDs, EU IMPDs, BLAs, and related regulatory submissions for biologics and gene therapy products.
• Develop and implement regulatory strategies for Nonclinical and CMC content in alignment with applicable FDA, EMA, ICH, and regional regulatory requirements.
• Review technical documents and source information to ensure accuracy, consistency, completeness, and regulatory compliance.
• Coordinate cross-functional inputs from CMC, Analytical Development, Process Development, Manufacturing, Quality, Nonclinical, Clinical, and Regulatory teams.
• Provide regulatory guidance on document content, submission requirements, timelines, and dossier structure.
• Support preparation and maintenance of content for Module 2 and Module 3 and other required modules, as applicable, including CMC summaries and detailed CMC documentation.
• Support preparation and review of Nonclinical sections, including relevant summaries and study documentation for regulatory submissions.
• Work closely with regulatory publishing teams on dossier preparation, compilation, hyperlinking, validation, quality checks, and submission.
• Demonstrate hands-on experience with eCTD 4.0 submissions, including understanding of eCTD structure, lifecycle management, metadata, and submission requirements.
• Manage regulatory submission content and associated documentation using Veeva RIMS or comparable Regulatory Information Management systems.
• Ensure regulatory documents and submission components are appropriately tracked, version-controlled, and maintained throughout the product lifecycle.
• Identify submission gaps, inconsistencies, and potential regulatory risks and work with stakeholders to resolve them proactively.
• Support responses to FDA/EMA regulatory questions and information requests, including coordination and compilation of responses.
• Participate in submission planning, tracking, and governance meetings and communicate project status, risks, and dependencies to relevant stakeholders.
• Contribute to process improvements, standardization, and implementation of best practices for Nonclinical/CMC regulatory submissions.
• Mentor junior regulatory professionals and provide guidance on submission processes, regulatory documentation, and dossier management

QUALIFICATIONS & EXPERIENCE

• Bachelor's or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, or a related discipline.
• 10–12 years of relevant experience in Regulatory Affairs, with significant experience in Nonclinical and/or CMC regulatory submissions.
• Hands-on experience with biologics, gene therapy, cell & gene therapy, or other advanced therapeutic products is strongly preferred.
• Demonstrated experience supporting or leading US IND, EU IMPD, and BLA submissions.
• Strong knowledge of FDA and EMA regulatory requirements, as well as applicable ICH guidelines and global submission standards.
• Proven hands-on experience in authoring, reviewing, and compiling Nonclinical and CMC regulatory content.
• Strong understanding of CTD/eCTD structure and submission lifecycle management.
• Hands-on experience working with eCTD 4.0 submissions.
• Experience with Veeva RIMS or equivalent Regulatory Information Management platforms.
• Experience collaborating with regulatory publishing teams on dossier compilation, QC, validation, and submission.
• Strong project management and cross-functional coordination skills.
• Excellent technical writing, editing, communication, and stakeholder-management skills.
• Ability to manage multiple priorities and deliver high-quality regulatory submissions within aggressive timelines

Required Add-ons

• Experience with gene therapy/viral vector-based products, including AAV or other vector platforms.
• Exposure to CMC regulatory requirements for cell and gene therapy products.
• Experience supporting regulatory interactions and agency responses with FDA and EMA.
• Experience with global regulatory submissions beyond the US and EU.
• Knowledge of regulatory submission publishing tools and platforms such as Veeva Vault/eCTD or equivalent systems.
• Experience working in a matrixed, global pharmaceutical, biotechnology, or CRO environment

WORKING CONDITIONS

This position operates in an office setting, in person.

Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

PHYSICAL REQUIREMENTS

This is a largely sedentary role and will have interactions with different cross functional teams.

DIRECT REPORTS

N/A