The primary responsibility of the Manager, Regulatory Affairs is to support the clinical study team in the preparation of Clinical Trial Applications and Investigational New Drug Application filings along with the associated regulatory documentation (amendments, labeling, responses to deficiencies, etc.) in a global environment. This position is also responsible for maintaining the official regulatory files, establishing basic procedures for efficient functioning of Regulatory Affairs department and representing Regulatory Affairs on the global study teams.
Roles & Responsibilities:
Participate in the development and implementation of regulatory strategies
Prepare CTA/IND filings and associated regulatory documentation (amendments, labeling, responses to deficiencies, etc.) in a global setting
Represent and appropriately communicate the Regulatory Affairs viewpoint in the global study team and CRO partners
Write and review all types of documents for submission to regulatory authorities, ethics committees, CRO partners, etc.
Prepare annual reports, safety reports, amendments and other correspondence for regulatory authorities
Ensure that sound regulatory practices are fully integrated in all clinical, pre-clinical and technical submissions
Interact with consultants and contractors as needed to meet the company’s goals
Understand regulations, guidelines and other regulatory requirements; share this understanding with the rest of the organization
Prepare for and participate in meetings and teleconferences with regulatory authorities
Maintain the Aurinia regulatory files to ensure an accurate and easily accessible record of the company’s interactions with regulatory authorities
Provide support to NDA/MAA filings as requested
Exercises good judgment within generally defined practices and policies
You agree to comply with all signatory limits, policies, rules, and regulations as set out and communicated by the company pursuant to good business practice.
Location: Victoria, BC (Preferred) or Vancouver/Seattle Home Based (may be considered for right candidate)
University degree in a health-related field
Minimum 5 years experience in pharmaceutical industry regulatory affairs (global experience preferred)
Ability to assimilate complex technical concepts and summarize appropriately for use with regulatory authorities
Familiar with most recent trends in electronic submissions and global standards (eCTD)
Proven, first-hand experience working in a fast-paced team environment
Willingness to explore alternatives in gaining approval of drugs
Ability to maintain high attention to detail while working under stringent timelines and minimal resources
Well-developed skill and comfort working with MS Office tools (Word, Power Point, Excel, Outlook)
Strong management and communication skills, as well as technical writing ability
CMC Regulatory experience (an asset)
Late Stage Development & Commercialization experience (an asset)
RAC designation (an asset)
Additional Salary Information: Salary range quoted is in Canadian Dollars
Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies in disease areas of high unmet medical need. We are currently developing voclosporin, an investigational drug, for the treatment of lupus nephritis (LN), focal segmental glomerularsclerosis and minimal change disease (MCD). Additionally, we are advancing voclosporin ophthalmic solution (VOS), a topic formulation, for the treatment of dry eye syndrome (DES).