Intrinsik is a North American consulting firm focusing on the regulatory challenges associated with the development of new products (pharmaceuticals, biologics, consumer products, natural health products and cosmetics). We are continuing to grow, and will always welcome candidates with strong scientific skills, creativity and enthusiasm to join our team.

Intrinsik has an opening for a Senior Associate, Regulatory Affairs / Regulatory Affairs Specialist. This is a hybrid position in any of the following locations:

• Raleigh, North Carolina, USA
• Mississauga, Ontario, Canada
• Montreal, Quebec, Canada

This position involves strategic oversight and project management of regulatory submissions to Health Canada and the United States Food and Drug Administration (including Clinical Trial Applications, Investigational New Drug Applications, New Drug Submissions and New Drug Applications). The successful candidate will have a broad base of regulatory experience, and must be able to provide leadership, mentor staff, and develop and execute strategy. The successful candidate must also be able to generate submission content (i.e., review and, if necessary, author scientific documents) for use in regulatory submissions.

We aim to offer our employees an environment that encourages professionalism, creativity, independence and continual learning. The assets of any knowledge-based company are its people, and we believe strongly in investing in those assets by offering training and mentoring of our employees. We are committed to growing and advancing our employees’ careers by providing them with new responsibilities and opportunities within the company.

Responsibilities include:

• Preparation of regulatory submissions (CTA, IND, NDS, NDA, etc.) and related documentation, such as pre-submission meeting briefing documents.
• Authoring of content for regulatory submissions, regulatory strategy documents and other reports for Intrinsik’s clients.
• Preparation of CTD Module 1 documents.
• Preparation of Health Canada specific regulatory templates (e.g. QOS, CPID, PSEAT, CS:BE).
• Interpretation of regulatory requirements and guidance.
• Regulatory and/or scientific paper-based research as needed.
• Client interaction, as needed, to coordinate document preparation and review activities.
• Quality control of content of outgoing documents and regulatory submissions.

The successful applicant(s) would ideally have the following qualifications:

• Minimum BSc in Life Sciences.
• Postgraduate Certificate in Pharmaceutical Regulatory Affairs is an asset.
• Minimum of 5 years of hands-on experience in Regulatory Affairs.
• Experience in the preparation and maintenance of new active substance submissions (both investigational and marketing applications).
• Understanding of the regulatory process for drug development.
• Sound knowledge of the current Canadian regulations, guidance and policy; and working knowledge of FDA requirements is an advantage.
• Strong project management skills.
• Prior experience with electronic submissions and strong computer technical skills.