Having commenced operations in 2006, Aquinox Pharmaceuticals Inc. is a privately-held pharmaceutical company developing targeted small molecule therapeutics for the treatment of cancer and inflammatory disease. The Company has a strong intellectual property portfolio and library of pre-clinical drug candidates that target a unique biochemical enzyme called "SHIP" (SH2-containing inositol phosphatase) which regulates the PI3 kinase (PI3K) pathway. Outstanding technology coupled with an exceptional management team and a recently completed US $14.5 million financing make it a very exciting time to seize this wonderful opportunity.

We are currently looking for a Manager, Regulatory Affairs who will serve as a liaison between the company, CRO's and regulatory agencies for all assigned projects and who is responsible for day to day regulatory support. This individual is expected to provide guidance within Regulatory Affairs and all other data generating departments to ensure timely filing and approval/maintenance of assigned programs.

Responsibilities include project support and planning for assigned programs and also include, but are not limited to, the following activities:

• Represent Regulatory Affairs at various project team and working group meetings.
• Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
• Contribute to the development of regulatory and product development strategy plans.
• Manage submission activities (pre-IND, IND/CTA, trial maintenance) and health authority interactions (meeting requests and briefing documents).
• Prepare orphan drug designation and fast track development requests.
• Ensure the quality and content of all submissions to health authorities.

To be successful in this role, you will have the following qualifications and experience:

• A minimum 4-year degree in a scientific or technical discipline; advanced degree helpful
• The ideal candidate should have 3-5 years of regulatory experience in the biotechnology or pharmaceutical industry
• Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements
• EU, Canada, ROW experience helpful
• Previous experience in supporting submission teams for NCE pre-IND applications and/or clinical trial applications is required
• Candidates must be able to demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral)

Interested candidates are invited to forward their resume and cover letters to careers@aqxpharma.com. Please use the title of the position as the subject line and indicate where you saw this posting. Aquinox would like to thank all interested applicants for their interest; however, only those chosen for an interview will be contacted.