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Associate Director Regulatory Affairs, Quality and Safety

1 hour ago

Fredericton, New Brunswick, Canada Ferring Full time
Job Description:

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 Associate Director of Regulatory Affairs, Quality Assurance and Pharmacovigilance you will be accountable for leading regulatory and quality activities for Ferring Canada's portfolio. We expect you to develop and execute Canadian regulatory and quality strategies that ensure compliance with Health Canada requirements, cGMP standards, and Ferring quality policies, while supporting business objectives and patient access.

You will provide leadership to a local RA/QA team, serving as Ferring Canada's primary interface with Health Canada, and act as a trusted partner to internal and external stakeholders.

Your day at Ferring

  • Develop and execute regulatory strategies for new products and lifecycle management activities in Canada.

  • Lead the preparation and submission of regulatory applications to Health Canada (NDS, SNDS, INDs, notifiable changes, medical device submissions).

  • Monitor submission progress and lead timely, high-quality responses to Health Canada questions and deficiency letters.

  • Identify regulatory risks and propose pragmatic, compliant solutions to support business and patient needs.

  • Oversee the local Quality Assurance function, ensuring compliance with cGMP and Ferring quality systems.

  • Accountable for product release, quality documentation, and quality system activities including deviations, CAPAs, validations, APQRs/YBRs, and change controls.

  • Lead and participate in Health Canada GMP inspections and internal audits.

  • Ensure maintenance of Establishment Licenses (DEL, NHP, MDEL, MDL).

  • Oversee product recalls, when required, in coordination with Global Quality.

  • Lead, coach, and develop RA/QA team members, including performance management and development planning.

  • Foster a collaborative, accountable, and solutions-oriented team culture.

Behind our Mission… There's you

  • University degree in a scientific discipline (Pharmacy preferred); Master's degree an asset.

  • Approximately 8–10 years of experience in Regulatory Affairs and/or Quality Assurance within the Pharmaceutical or biotechnology industry.

  • Proven experience working with Health Canada and preparing Canadian regulatory submissions.

  • Strong knowledge of Canadian regulatory requirements and cGMP.

  • Confident, influential, and collaborative leadership style.

  • Strong regulatory strategy and problem-solving skills.

  • Ability to challenge constructively and navigate complex stakeholder environments.

  • Excellent communication skills in English, written and verbal.

  • Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment.

People come first at Ferring


• Ferring commits to advocate for everyone's right to build a family, no matter who you are, where you live or who you love.

• Our inclusive support package – "Building Families at Ferring" provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role. Subject to a minimum period of employment at Ferring.

• Parental leave for both birthing and non-birthing parents.

• Extended support on family building journey.

Making a difference in the life of millions of people means we succeed by working together.

Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member's contributions. Imagine the power of your career when it's Ferring + You.

Behind our purpose… There's you

If our mission and your vision are aligned, please apply

We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.

Note to agencies: this search is being managed by Ferring's Talent Acquisition team. Kindly do not send us spontaneous profiles.

Location:Ferring Canada