Senior Regulatory Affairs Associate

Job summary

Prepare and manage regulatory submissions and lifecycle activities for biologic drug and medical device products in Canadian and international markets. Monitor regulatory requirements, assess quality and manufacturing changes, support promotional material reviews, and maintain accurate regulatory records while collaborating with internal teams.

Job details

About Our Client BLES Biochemicals Inc. is a Canadian pharmaceutical company making a meaningful impact in neonatal respiratory care. BLES has built a highly specialized portfolio focused on supporting some of the most vulnerable patients - newborn infants requiring respiratory care. Its portfolio includes BLES, a biologic drug product, and BLEScath, a medical device, with products supported across Canadian and international markets. BLES is looking for a Senior Regulatory Affairs Associate to join its team and take an active role in supporting the regulatory lifecycle of both its biologic drug and medical device portfolio. Reporting to the Head of International Regulatory Affairs, this is a hands-on, high-impact role with exposure to both Canadian and global regulatory environments. What You’ll Be Doing You’ll work across the organization, partnering with business, marketing and operational teams on everything from regulatory submissions and product lifecycle maintenance to evolving global requirements and manufacturing changes.It’s an opportunity to bring your regulatory expertise to a smaller, specialized pharmaceutical environment where your work is visible, your contribution matters, and you can have a direct impact on products supporting neonatal care. Essential Responsibilities: Prepare, compile, file and monitor regulatory submissions for BLES Biochemicals’ biologic drug product and medical device in international markets, working with limited supervision. Support the preparation of Health Canada submissions in electronic Common Technical Document (eCTD) format, including Notifiable Changes, annual reports and renewals. Maintain the lifecycle of existing drug product and medical device registrations in Canada and internationally, helping ensure regulatory obligations are addressed throughout the life of the registered products. Monitor domestic and international regulatory sources, including Health Canada, the International Council for Harmonisation (ICH) and other relevant international authorities and sources, for emerging or revised requirements affecting drug products and medical devices. Review new and revised regulations and guidelines and assess their potential impact on BLES Biochemicals’ registered products and ongoing regulatory obligations. Evaluate proposed quality and manufacturing changes to determine potential regulatory impact across global markets and identify requirements associated with maintaining compliant registrations. Work cross-functionally with business, marketing and operational teams to support regulatory compliance while remaining mindful of business objectives and timelines. Assist with the regulatory review of marketing and promotional materials to help ensure materials are appropriate from a regulatory perspective. Maintain organized, accurate and current regulatory electronic files and documentation for BLES Biochemicals. Support additional regulatory priorities and assignments as required by the Head of International Regulatory Affairs. Performance Expectations Include: Manage multiple regulatory projects and deliverables at the same time, establishing clear goals, priorities and timelines for completion. Demonstrate sound regulatory judgment and the ability to anticipate challenges, work through issues and identify practical paths toward regulatory compliance. Apply a strong understanding of pharmaceutical development and manufacturing processes when evaluating submissions, product lifecycle activities and proposed quality or manufacturing changes. Interpret Canadian and international drug and medical device regulations and guidelines and translate changing requirements into practical regulatory actions. Bring strong analytical and problem-solving skills to complex or evolving regulatory issues, including situations where the impact of a change must be assessed across more than one market. Produce high-quality regulatory documentation with a strong level of accuracy, organization and attention to detail. Communicate clearly and professionally, both verbally and in writing, and collaborate effectively with internal business, marketing and operational teams as well as external stakeholders. Work with an appropriate degree of independence and ownership while escalating issues or seeking direction when required. Maintain well-organized regulatory records and electronic files so that documentation is complete, current and readily accessible. Stay current on emerging regulatory expectations affecting biologic drug products and medical devices. What We Are Looking For: University degree in Life Sciences, such as biology, chemistry, pharmacology or a related scientific discipline. Post-graduate certification in Regulatory Affairs. Minimum of 3–5 years of hands-on regulatory affairs experience within pharmaceuticals, biologics and/or medical devices. Strong understanding of pharmaceutical development and manufacturing processes. Strong knowledge and understanding of Canadian and international drug and medical device regulations and guidelines. Demonstrated ability to anticipate regulatory challenges and work through issues to achieve and maintain compliance. Proven ability to manage several projects simultaneously, including establishing specific goals and timelines and following work through to completion. Exceptional analytical and problem-solving skills, with the ability to assess the implications of regulatory, quality and manufacturing changes. Excellent written and verbal communication skills and the ability to work effectively with internal and external teams. Strong attention to detail and a disciplined approach to regulatory documentation and file management. Proficiency with Microsoft Office Suite, Google Workspace and Adobe Acrobat. Familiarity with eCTD submissions is considered an asset. Why This Opportunity This role offers the opportunity to work within a specialized Canadian pharmaceutical company focused on neonatal respiratory care, while gaining exposure to both a biologic drug product and a medical device. The Senior Regulatory Affairs Associate will contribute across Canadian and international regulatory activities and will have direct involvement in product lifecycle maintenance, submissions, regulatory intelligence, change assessment and cross-functional compliance support. For consideration, please apply online. As part of our commitment to inclusivity, diversity, equity and accessibility, our goal is a workforce built on respect that reflects the communities we serve. We thank all applicants for their interest, but only those selected for an interview will be contacted.

What you’ll do

Prepare and manage regulatory submissions and lifecycle activities for biologic drug and medical device products in Canadian and international markets. Monitor regulatory requirements, assess quality and manufacturing changes, support promotional material reviews, and maintain accurate regulatory records while collaborating with internal teams.

Requirements

Requires a university degree in life sciences and postgraduate certification in Regulatory Affairs, with 3–5 years of hands-on experience in pharmaceuticals, biologics, and/or medical devices. Candidates should understand Canadian and international regulations, pharmaceutical development and manufacturing, and be able to manage multiple projects, assess regulatory impacts, and produce accurate documentation.

Listed skills

• Regulatory Compliance · Preferred
• Project management · Preferred
• Cross-Functional Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory Affairs
• Regulatory Submissions
• eCTD
• Product Lifecycle Management
• Regulatory Intelligence
• Canadian and International Regulations
• Biologics
• Medical Devices
• Pharmaceutical Development
• Manufacturing Change Assessment
• Regulatory Compliance
• Project Management
• Analytical and Problem-Solving Skills
• Regulatory Documentation
• Cross-Functional Collaboration
• Microsoft Office, Google Workspace, and Adobe Acrobat

Job areas

• Healthcare
• Legal
• Science & Research
• Manufacturing

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