Overview
Director, Scientific Affairs Jobs in Mississauga – Ontario at Pharmaprix
Title: Director, Scientific Affairs
Company: Pharmaprix
Location: Mississauga – Ontario
Category: Pharmaceutical, Healthcare
Referred applicants must not apply directly to this role. All referred applicants must use their unique referral link generated when they are referred by an existing colleague.
Location:
1685 Tech Ave, Mississauga, Ontario, L4W 0A7
At Shoppers Drug Mart, we’re innovating health and
wellness
in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we’re caring and supporting our customers in new ways every day.
With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers Drug Mart network is more than a great place to shop, it’s a great place to work.
We’re committed to building our talented team who champion
collaboration
, kindness and inclusivity.
Join our team
, and help recognize a healthy future for your career and for all Canadians.
Why this role is important?
Reporting directly to Senior Director,
Quality Assurance
, the incumbent will be responsible for
strategic leadership
and functional management of Regulatory Affairs, Pharmacovigilance and
Patient Safety
Compliance programs. Supporting various business units within the Shoppers Drug Mart and Loblaw Companies Limited portfolio, this role will ensure compliance with established procedures, relevant regulations, client requirements and industry guidelines. The incumbent is a proven leader capable of engaging with key stakeholders across all levels of the organization to implement requirements and translate business goals into the strategic quality plan.
Duties:
As an active member of the Healthcare Businesses Compliance Team, the Director, Scientific Affairs plays a pivotal role in supporting development of business strategy and provides audit
leadership
, pharmaceutical client PV
leadership
and direction in establishing and maintaining Regulatory licenses, Pharmacovigilance and
Patient Safety
processes in compliance with established procedures, relevant regulations, client requirements and industry guidelines. Regulatory Affairs Oversee maintenance and submission of establishment licences, including Drug Establishment Licenses (DEL) and Medical Device Establishment Licences (MDEL) for all business units within the Healthcare Businesses portfolio.
This includes, but is not limited to application for new licenses, revision or changes to existing licences, and annual license renewals.
Oversee preparation and filing of all regulatory documents at the Federal and Provincial levels.
Oversee intake and analysis of new and revised regulations and standards for impact to established procedures impacting the Healthcare Businesses Quality Management System (QMS). Support consultation activities and work with key stakeholders to define risks and action plans as required.
Oversee development of regulatory strategy for marketed and pipeline products, Supplemental New Drug Submissions, ANDS, Notifiable Changes, and Notifications Oversee preparation and filing of all regulatory documents at the Federal and Provincial levels
Oversee review of promotional materials, labeling and artwork
Patient Support Program (PSP)
Leadership
& Compliance Act as advisor on all Pharmacovigilance and
Patient Safety
matters to support maintenance of existing Patient Support Programs (PSPs)
Act as primary client point of contact for …
