CMC Regulatory Consultant
Canada, Ontario, Hamilton
Parttime: 10 hrs a week / CA$ 100 - 150 per hour
Experience: From 6 years
Pharmaceuticals
Introduction
CMC Regulatory Consultant (6-month contract, 10 hours per week)
Hamilton, ON
What are you going to do
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.
Essential skills and knowledge
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.
What we offer
What We Offer
Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We'll get you going while you get on with the job.
About Us
Brunel has a reputation for working with some of the best in the business. That's what we continually strive for. Over 45 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.
#BRUCAD
Anything else ?
Shape your future
Are you ready for the next step in your career? Join Brunel’s powerful global network, where passionate, results-driven specialists come together with industry-leading clients. By connecting specialists to pioneering projects, we drive change in many industries, enabling growth and delivering great outcomes. Brunel helps you reach your full potential and empowers you to make an impact within a purpose-driven global company.
Explore your career opportunities!
Explore your career opportunities!
Our Culture and Values
At Brunel, we are proud of our unique corporate culture, which is shaped and nurtured by the collective efforts of our employees. Our work environment is characterised by an authentic, communicative and inclusive approach to teamwork that fosters an atmosphere of collaboration and creativity. Our values are at the center of everything we do – for our clients, our colleagues and ourselves.
Learn more about our global network of specialists!
Learn more about our global network of specialists!
Our ESG Commitment
Since 1975, our mission has always been to connect specialists to exciting career opportunities, to support the development of these careers, and to offer fair and equal employment. This has enabled us to create a truly sustainable and durable business model. Having a passion for people and caring deeply for the environment is not only part of Brunel’s DNA but is also reflected in our culture and values. As a global company, we take our social responsibility very seriously.
Join us on our mission!
Join us on our mission!
Are you the perfect match for this vacancy? Apply in 1 minute and let's get in touch!
