Regulatory Affairs & Quality Senior Specialist

Ferring Pharmaceuticals•North York, ON

1d•CA$80,000 - CA$119,000•Onsite

About The Position

At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world. Every person at Ferring works together to change lives and help people build families. Our Commercial teams collaborate as trusted partners with patient groups, clinicians, policy makers and the scientific community to identify and develop new opportunities to help patients. We are a customer centric organization and we offer an empowering, entrepreneurial culture – and a place to thrive and grow. To reach our full potential we collaborate, respect and value diverse contributions so that we can grow as an organization and as professionals. Together we can influence the world around us to make life and work better. Ferring+You As our Senior Specialist of Regulatory Affairs and Quality Assurance you will be accountable for supporting the regulatory and quality activities for Ferring Canada’s portfolio. We expect you to ensure timely approvals and ongoing Regulatory & Quality compliance of approved products considering Health Canada requirements, cGMP standards, and Ferring quality policies, while supporting business objectives and patient access. You will apply advanced Regulatory knowledge and showcase the ability to work independently and proactively on complex matters. Quality experience is essential, for supporting the responsibilities of the department. We also expect that given your seniority, you will act as a mentor for our junior team members. This role is a replacement position, created to ensure continuity and ongoing excellence in Regulatory Affairs and Quality Assurance for Ferring Canada.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related scientific discipline is required.
5+ years of progressive regulatory affairs experience within pharmaceuticals or biotechnology industries.
Proven experience working with Health Canada and preparing Canadian regulatory submissions.
Strong understanding of regulatory strategy, process, and change control.
Experience in document lifecycle management and continuous monitoring activities.
Understanding and capability to support Quality functions
Ability to manage multiple projects independently with limited supervision.
Strong analytical, problem-solving, and communication skills.
Proven ability to collaborate effectively across functions and build cooperative relationships within the company and with Health Canada.
Proactive individual with high work ethic.
Excellent communication skills in English, written and verbal.
Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment.

Responsibilities

Manage and support regulatory submissions including product registrations, amendments, supplements, and periodic reports.
Provide regulatory guidance and strategic input to cross-functional teams throughout the product lifecycle.
Act as regulatory liaison with health authorities to support submissions, address inquiries, and facilitate approvals.
Coordinate, compile, review, and maintain high-quality regulatory documentation in compliance with internal and regulatory standards.
Support regulatory strategy development, risk management, and implementation planning.
Identifying and acting on opportunities to maximize the potential of the product portfolio.
Ensure pre-clinical and clinical trial documentation aligns with regulatory requirements.
Provide Regulatory input and ensure requirements are met for CMC submission.
Support post-approval regulatory maintenance, including labeling updates and manufacturing changes.
Help with DEL maintenance, SOPs, change controls, CAPAs, deviations and other Quality responsibilities.
Coach and review work of junior regulatory professionals as appropriate.