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Biologics, Canadian Regulatory Affairs, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
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 will always welcome candidates with strong scientific skills, creativity and enthusiasm to join our team.
Intrinsik has an immediate opening for a Regulatory Affairs Senior Associate – CMC within North America. This position involves authoring Chemistry, Manufacturing and Controls (CMC) documentation for regulatory projects related to marketing applications as well as clinical trial applications/investigational new drug applications for the US and Canada. The CMC team at Intrinsik authors documents for a wide range of novel and innovative biologic and small molecule products.
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.
Authoring of the CMC modules from source data for regulatory submissions for Health Canada and the US Food and Drug Administration.
Critical assessment of data and documents to identify gaps compared to regulatory requirements for Canada and the US.
Assist in the development of regulatory strategies for CMC and support with regulatory research as needed.
Quality control of the content of outgoing documents and regulatory submissions.
Client interaction, as needed, to coordinate document preparation and review activities.
Assist in preparation of electronic submissions for regulatory authorities.
The successful applicant(s) would ideally have the following qualifications:
Minimum BSc in Life Sciences.
A minimum of 5 years of hands on experience in regulatory submission preparation.
Candidates must have experience in the preparation of the CMC modules (both investigational and marketing applications). Experience with biologics is strongly preferred.
Understanding of the regulatory process for drug development. Good working knowledge of Canadian and/or US regulations, guidance and policy.
Prior experience with electronic submissions is strongly preferred.
The successful applicant(s) would ideally have the following attributes:
Excellent attention to detail.
Ability to multi-task and coordinate project activities.
Strong written and verbal communication skills.
Initiative, with the ability to research and complete projects in an independent manner.
Good interpersonal skills, with the ability to work well in a team environment.
Interested candidates may submit their resumes via e-mail to Heather Wilson at firstname.lastname@example.org. We thank all candidates for applying; however, only those considered for an interview will be contacted by Human Resources.
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About Intrinsik Ltd.
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.