Senior Regulatory Associate New Product Development and Medical Devices

Job summary

The role involves compiling and submitting regulatory dossiers for pharmaceuticals and medical devices in accordance with Health Canada and ICH requirements. It also requires conducting regulatory assessments for post-approval changes and collaborating with internal stakeholders to support product launches.

Job details

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and presence in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. WHAT WE OFFER! Benefits At Fresenius Kabi Canada we foster a collaborative environment where employees are encouraged to share ideas and contribute to meaningful work. We offer unique learning opportunities to grow and build your career. In addition, we value each and every contributor and offer various benefits and rewards (as applicable) including: Company paid health and dental benefits that start on your first day of employment Generous vacation plan Paid float days and paid sick days Employee assistance program Casual office dress code Employee recognition program Perkopolis & Goodlife Discounts Professional growth and development opportunities We are currently seeking a full-time temporary (12 months) Senior Regulatory Associate New Product Development and Medical Devices to join our team! Hybrid role, on-site requirement 3 days/week Location - 165 Galaxy Blvd., Toronto ON (Pearson Airport Area) The pay range for this role is: $90,000.00 - $100,000.00. Placement within the range will be determined based on relevant skills, experience, qualifications, and internal equity. The final offer will reflect the successful candidate's background and demonstrated capabilities. This position is an existing vacancy within the organization. Main Responsibilities Participates actively in project team meetings and provides Canadian regulatory requirements to the respective functions within the project team in accordance to the current Health Canada and ICH requirements Compiles and submits regulatory dossiers (e.g. NDSs, ANDSs, SNDSs, SANDSs, and other applications) or medical device regulatory applications in accordance to the current Health Canada guidance documents as required Conducts accurate regulatory assessment for post-approval changes for pharma and devices and identifies level of filing and data requirements Communicates with internal and external stakeholders to obtain application documents Supports the Quality and Marketing Departments in the change control and product launch processes as required Manages own projects independently as per assigned deadline and reports any delays to management Provides regular reports to management on the status of regulatory submissions, licenses/clearances and registrations Qualifications Bachelor of Science Degree in one of Chemistry, Microbiology, Biology, Pharmacology or other life science is required at minimum Completion of a college regulatory affairs program is an asset Minimum of four years of pharmaceutical experience in a regulatory affairs capacity for pharma and/or medical devices Skills Strong knowledge of chemistry and manufacturing requirements for pharmaceuticals Strong knowledge of Health Canada Medical Device regulations and understanding of global regulatory requirements Strong communication skills (written and verbal) Able to understand customer needs and the ability to collaborate both inside and outside the organization Strong computer skills in Microsoft Office 365®. Adobe Acrobat and familiarity with eCTD Document Management System are required. Strong attention to detail Self-motivated Proven ability to adhere to standards and procedures and maintain confidentiality Strong commitment to quality and accuracy Analytical skills to assess problems and present solutions are required Ability to work well under pressure in a team-based environment MORE ABOUT US! As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. Inclusion and Equal Opportunity Employment At Fresenius Kabi Canada, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work. We are taking actions to tackle issues of inequity and systemic bias to support our diverse talent, clients and communities. We are an equal opportunity employer. In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, we are committed to providing accommodations and will work with candidates to meet their needs and provide an accessible candidate experience. If you are a person with a disability and require assistance during the application process, please let us know (hrcanada@fresenius-kabi.com). We welcome members of all backgrounds, experiences and perspectives to apply. Artificial Intelligence (AI) Use In Recruitment Fresenius Kabi uses AI-supported tools to help compare applicant résumés with job requirements and identify potential matches. These tools do not make hiring decisions. All candidate reviews, selections, and decisions are made by our recruitment team.

What you’ll do

The role involves compiling and submitting regulatory dossiers for pharmaceuticals and medical devices in accordance with Health Canada and ICH requirements. It also requires conducting regulatory assessments for post-approval changes and collaborating with internal stakeholders to support product launches.

Requirements

Candidates must have a Bachelor of Science in a life science field and at least four years of pharmaceutical regulatory affairs experience. Proficiency in eCTD systems and strong knowledge of Health Canada medical device regulations are required.

Benefits

• Health benefits • Dental benefits • Vacation plan • Paid float days • Paid sick days • Employee assistance program • Casual office dress code • Employee recognition program • Perkopolis discounts • Goodlife discounts • Professional growth and development opportunities

Listed skills

• Quality assurance · Preferred
• Collaboration · Preferred
• Attention to detail · Preferred
• Communication Skills · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory Affairs
• Health Canada Regulations
• Medical Device Regulations
• Dossier Compilation
• Post-approval Change Assessment
• Microsoft Office 365
• Adobe Acrobat
• eCTD Document Management System
• Communication Skills
• Analytical Skills
• Project Management
• Collaboration
• Attention To Detail
• Quality Assurance
• ICH Requirements
• Pharmaceutical Manufacturing

Job areas

• Healthcare
• Science & Research
• Manufacturing
• Legal
• Administrative