Director, Regulatory Affairs

Company: 

Are you looking for an opportunity to be involved in a great cause and to have a career in a rewarding and exciting organization?   Come be part of a passionate team whose mission is to find a cure for diabetes and its complications through the support of research.  If you’re looking for a fast paced organization with the opportunity for professional and personal growth, our client is the place for you!  Are you ready to make a difference??  Check out this exciting position currently available with the newly created Canadian Clinical Trial Network (CCTN)

There is currently an exciting opportunity for a highly motivated, resourceful and talented individual for the role Director, Regulatory Affairs based in our Toronto, Ontario office.

Responsibilities:

·         Overall planning and direction for the regulatory department.

·         Manage a growing staff that will work with cross functional teams with a primary goal of submitting IND applications to the FDA.

·         Bring Best Regulatory Affairs Practices into a well-funded start-up environment

·         Review CMC regulatory strategies.

·         Manage tight time lines and reallocate resources as necessary.

·          Provide technical data and/or solutions required by local forecast and logistics.

·          Provide Health Authorities approvals required for local Clinical trials

·          Identify major regulatory, clinical, technical or operational issues impacting on successful filing, approvals and variations/ maintenance and propose possible solutions

·         Clinical Trials Registration

·         Experience with Devices and Intervention

Qualifications:

·         Bachelors degree or higher in a scientific discipline.

·         Minimum 5 years regulatory experience and 8+ years in biotech or pharmaceutical companies.

·         Knowledge of SOP’s, cGMP’s, IND application’s, CMC, and experience working with the FDA (ICH and EMEA is preferred as well).

·         Experienced in staff and organizational development. 

·         Ability to adhere to strict project time lines and budgets.

·         Excellent communication and leadership skills

·         Ability to work in a fast-paced entrepreneurial environment

·         Self-motivated, team-player

·         Entrepreneurial thinker 

Interested candidates, please forward your resume as a WORD doc to: patricia@globalrecruit.com