What are the responsibilities and job description for the Regulatory Affairs & Quality Senior Specialist position at ferring?
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 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. Your day at Ferring 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. Behind our Mission… There’s you 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. People come first at Ferring We value your contribution: this role offers a salary range of $80,000 – $119,000 CAD annually, complemented by a comprehensive benefits package. 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 Ferring Pharmaceuticals a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in gastroenterology and urology, and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries. Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram, YouTube, Facebook and X. At Ferring, we'll give you the tools to shape a career build on purpose. Join us and help People around the world to build families and live better lives. Click HERE to enlarge the picture. At Ferring, our focus on Patient Advocacy drives our commitment to create more equitable health outcomes for all, at every stage of their healthcare journey. We believe in everyone’s right to access the best treatment, pioneering into new therapeutic areas, and developing innovative ways to diagnose, treat and prevent diseases. Don't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit!