Intrinsik is a North American consulting firm focusing on the regulatory challenges associated with the development of new products (pharmaceuticals, biologics, medical devices, consumer products, natural health products and cosmetics). We are continuing to grow, and we are seeking candidates with strong scientific skills, creativity and enthusiasm to join our team.
Intrinsik has an immediate opening for a Senior Manager, Regulatory Affairs. This is a remote position. This position involves strategic oversight and project management of regulatory submissions to Health Canada (including Clinical Trial Applications, New Drug Submissions and Supplemental New Drug 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 staff. Like all successful organizations, we are committed to growing and advancing our employees’ careers by providing them with new responsibilities and opportunities within the company.
Preparation of regulatory submissions (CTA, NDS, SNDS) 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.
Management of a portfolio of Intrinsik’s clients; this involves direct contact with the client, and management of not only scientific and regulatory aspects, but also business aspects such as contracts and budgets.
The successful applicant would ideally have the following qualifications:
Minimum BSc in Life Sciences.
Postgraduate Certificate in Pharmaceutical Regulatory Affairs is an asset.
Minimum of 8-10 years of hands-on experience in Canadian 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.
Familiarity with Health Canada processes and procedures.
Strong project management skills.
Prior experience with electronic submissions and strong computer technical skills.
As a recognized leader in the industry, our team of experts provide regulatory and scientific advice to help identify the most efficient drug development and registration pathways in a timely manner. As a science-based consulting firm with clients from all over the world, Intrinsik supports the development of a wide range of human health products, including small molecules, biologics, natural health products, cosmetics, medical devices, and food additives and ingredients from the preclinical stage through to market and the post-approval phase.