CAREERS

Intrinsik Health Sciences Inc., a Canadian consultancy whose focus is to address the toxicology and regulatory challenges associated with the development of products (pharmaceuticals, biologics, medical devices, consumer products, natural health products and cosmetics), is always looking for people with strong scientific skills, creativity and enthusiasm to join our team. Intrinsik has immediate openings for a Regulatory Affairs Associate and a Senior Administrative Assistant/Submission Coordinator in our Mississauga location. 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 Associate

The position would involve providing a full range of regulatory support to the Senior Manager and Vice President of Regulatory Affairs, including submission preparation and document authoring.

Job Description

• Preparation of regulatory submissions (NDS/NDA, IND/CTA, DIN submissions) for Health Canada, FDA and possibly other regulatory agencies.
• Preparation of CTD modules, e.g. quality from source data on behalf of Intrinsik clients.
• Preparation of Health Canada or FDA specific templates e.g. QOS, PSEAT, Question Based Review summary.
• Understanding of the regulatory process for drug development, support with regulatory research as needed to assist in the development of regulatory strategies.
• Critical assessment of data and documents to identify gaps compared to regulatory requirements for US and Canada.
• Client interaction as needed to coordinate document production and review activities.

• Minimum BSc in Life Sciences.
• A MINIMUM of 3 to 5 years of hands on experience in regulatory submission preparation, EXCLUDING student co-op level experience is a firm requirement for this position.
• Candidates MUST have experience in new active substance submissions.
• A regulatory CMC background is preferred; concomitant experience/comfort with clinical aspects of drug development is an advantage.
• Good working knowledge of Canadian regulations, guidance and policy; working knowledge of FDA requirements is an advantage.
• Experience with electronic submissions is an advantage.
• Intrinsik is also seeking excellence in the following attributes:
  • Attention to detail.
  • Ability to multi-task and coordinate project activities.
  • Written and spoken communication.
  • Computer skills, particularly using MS Word and Adobe.
  • Initiative.

• rovide advanced level word processing support to all Intrinsik Health staff, to ensure standardized report, proposal, and submission production according to Intrinsik requirements using the Intrinsik Health Sciences Style Guides and Standard Operating Procedures.
• Assist with administrative aspects of project planning for submissions, including the production, publication and binding of professional reports, and creation of eCTD compliant submission documentation in PDF.
• Assist with technical issues relating to publishing documents using Microsoft Office or Adobe Acrobat.
• Train / assist with submission publication using specialized eCTD submission software system.

• Assist in the development of SOPs to ensure the efficient production of consistent and high quality submission documents and reports.
• Quality control checks on reports and submission documentation for consistency with Intrinsik standards and SOPs.
• Ensure rapid (and in some cases same day) production of high quality submission documentation in conformance with Regulatory and corporate standards.

• General administrative duties, including travel arrangements, assistance with client contracts and agreements, marketing mail outs, supply orders, and other Corporate promotional items as needed.
• Co-ordinate monthly staff loading spreadsheets and attend monthly projects meeting.
• Assisting other Intrinsik groups (Corporate and Environmental) with admin overflow and special projects.

• A minimum of five years of administrative office experience.
• Experience with regulatory coordination activities preferred.
• Candidates should be able to demonstrate strong written and oral communication skills in combination with a facility for technical detail.
• Familiarity with common computer programs is expected, including strong proficiency in Microsoft Office 2007, and particularly Microsoft Word and Adobe Acrobat.
• Ability to work independently and as part of a team.
• Ability to multi-task (multiple projects/issues) and react to changing situations.