Regulatory Affairs Consultant (US Based)
Intrinsik Health Sciences Inc. is a Canadian consulting firm focusing on the toxicology and 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 Consultant. 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.
Regulatory Affairs Consultant
The position involves management of regulatory projects related to U.S. marketing applications and investigational new drug applications. The position will provide support to the Director and Vice President of Regulatory Affairs, and includes submission preparation and document authoring.
- Preparation of regulatory submissions for FDA, NDA, IND and other regulatory agencies.
- Preparation of CTD modules, e.g. quality and clinical, from source data.
- Assist in the development of regulatory strategies and support with regulatory research as needed.
- Critical assessment of data and documents to identify gaps compared to regulatory requirements for the U.S.
- Quality control of the content of outgoing documents and regulatory submissions.
- Client interaction, as needed, to discuss strategy, coordinate document production and review activities.
The successful applicant(s) would ideally have the following qualifications:
- Minimum BSc in Life Sciences.
- A MINIMUM of 8 years of hands on experience in regulatory submission preparation, excluding student co-op/internship level experience, is a firm requirement for this position.
- Candidates MUST have experience in the preparation and maintenance of new active substance submissions (both investigational and marketing applications).
- Understanding of the regulatory process for drug development.
- Good working knowledge of U.S. regulations, guidance and policy.
- Strong strategic understanding of U.S. pharmaceutical development process.
- Experience in the NDA submission process and post approval change process.
Intrinsik is also seeking excellence in the following attributes:
- Attention to detail
- Ability to multi-task and coordinate project activities
- Strong writing skills
- Written and spoken communication
- Familiarity with common computer programs is expected, including strong proficiency in Microsoft Office, and particularly Microsoft Word and Adobe Acrobat
- Good interpersonal skills, with the ability to work well in a team
- Experience in advertising and promotion is considered an asset
Interested candidates may submit their resumes via email to Andrea Kalentizis , Human Resources Manager, at