CMC Regulatory Consultant
Canada, Ontario, Hamilton
Parttime: 10 hrs a week
Experience: From 6 years
Pharmaceuticals
CMC Regulatory Consultant (6-month contract, 10 hours per week)
Hamilton, ON
Job Descriptions
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.
Job Requirements
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.