CMC Regulatory Consultant

CMC Regulatory Consultant (6-month contract, 10 hours per week)

Hamilton, ON

Introduction

We are hiring a CMC Regulatory Consultant for one of our radiopharmaceutical clients based in Hamilton, Ontario. The CMC Regulatory Consultant reporting into the Director, Technical Operations, will support global regulatory interactions by leading the coordination, review and regulatory alignment of Health Authority Questions (HAQs) related to CMC. This role serves as the primary liaison between internal cross-functional technical SMEs and Regulatory Affairs, ensuring that SME-authored responses are aligned with regional regulatory expectations. The company has recently opened a state-of-the-art radiopharmaceutical manufacturing facility. The good manufacturing practice (GMP) compliant facility is now operational supplying patients for clinical trials. As part of the company’s radiopharmaceutical manufacturing department, the CMC Regulatory Consultant will support time critical CMC Regulatory HAQs. This role will liaise with other CMC and non-CMC functions, draft needed regulatory content and collaborate in cross-functional teams. This is a part-time position that involves up to 10 hours a week of ad-hoc work.

Responsibilities

• Serve as the CMC regulatory point of contact for global Health Authority Questions (e.g. FDA, EMA, MHRA, PDMA, other regions as applicable).
• Train on the company’s ERV/Veeva Vault system and manage HAQ responses within the ERV system
• Coordinate HAQ response development across internal technical teams.
• Track HAQs, response timelines, commitments, and dependencies to ensure on-time, high-quality submissions.
• Interpret and apply global/regional CMC regulatory guidelines and regulations.
• Review SME-drafted HAQ responses for regulatory appropriateness, clarity, consistency and alignment with regional CMC expectations.
• Extract and summarize scientific information from development reports and identify details required for regulatory submissions.
• Organize data to support the group’s function with answering questions, information request from regulatory agencies such as the FDA, Health Canada or EMEA (including relevant country specific authorities).
• Advise SMEs on how to frame technical data and rationales to meet Health Authority expectations.

Requirements

• Advanced degree in a scientific discipline (e.g. Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology,) or equivalent experience.
• 8+ years of experience in CMC Regulatory Affairs in the pharmaceutical and/or biotechnology industry.
• Prior radiopharmaceuticals experience is preferred.
• Experience with ERV (RIM) systems is preferred.
• Excellent regulatory writing and editorial skills.
• Hands-on experience managing and responding to global Health Authority Questions (HAQs).
• Strong understanding of CMC requirements for early and late phase development (IND/CTA, BLA/NDA/MAA).
• Extensive knowledge of eCTD structure and subsections, including appendices.
• Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing.
• Excels at working in a collaborative environment as a member of a multidisciplinary team.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Must have good time management skills, capable of timely delivery of CMC sections.
• Must be flexible and able to handle changing priorities.
• Ability to operate with an integrated view of CMC strategy risks/benefits and company needs.

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