About Company
At Career.zycto, we believe in connecting top-tier talent with groundbreaking opportunities. For Regulatory Affairs Specialists, our firm offers unparalleled access to leading pharmaceutical and biotech companies in Canada. We pride ourselves on understanding the nuanced demands of regulatory landscapes, ensuring our candidates are perfectly matched with roles that challenge and grow their expertise. Join a network that values precision, compliance, and strategic impact, helping you shape the future of healthcare innovation. We empower professionals to thrive in dynamic environments.
Job Description
Are you a meticulous and strategic Regulatory Affairs Specialist ready to make a significant impact on product development and market access within the pharmaceutical industry? Career.zycto is seeking a dedicated and experienced professional to join one of our esteemed clients in Pierrefonds, Montreal. This full-time, on-site role offers a dynamic environment where your expertise will be pivotal in navigating the complex landscape of health authority regulations, particularly those set forth by Health Canada.
In this critical position, you will be responsible for the end-to-end management of regulatory submissions, ensuring that all products meet stringent compliance standards from conception to post-market surveillance. Your day-to-day will involve a deep dive into scientific and technical data, translating complex information into clear, compliant regulatory dossiers. You’ll be a key liaison, fostering strong relationships with health authorities and providing essential regulatory intelligence to cross-functional teams, including R&D, Quality Assurance, and Marketing. Your strategic input will directly influence product development pathways, ensuring that innovative therapies can reach patients effectively and ethically. The commitment to patient safety and efficacy is at the core of every decision, and your role will be instrumental in upholding the highest standards.
This role is not just about compliance; it’s about foresight and proactive engagement. You will continuously monitor the evolving regulatory environment, assessing potential impacts on current and future products. Your ability to anticipate changes, interpret complex guidelines, and formulate adaptive strategies will be paramount. Success in this position requires not only a strong grasp of regulatory science but also excellent project management skills to juggle multiple submissions and deadlines. You will collaborate closely with various internal departments, providing expert guidance and ensuring a cohesive approach to regulatory challenges. We are looking for an individual who thrives in a detail-oriented setting, possesses exceptional analytical skills, and can communicate intricate regulatory requirements with clarity and confidence. If you are passionate about patient safety, committed to scientific integrity, and eager to contribute to bringing life-changing treatments to market, this opportunity promises immense professional growth and a chance to truly influence healthcare outcomes, advancing your career in a supportive and challenging environment.
Key Responsibilities
- Prepare, review, and submit regulatory documents, dossiers, and applications to Health Canada in accordance with established timelines and regulatory requirements.
- Ensure ongoing compliance with all relevant regulations, guidelines, and internal standard operating procedures (SOPs).
- Act as a primary liaison with Health Canada and other regulatory bodies, responding to inquiries and managing correspondence effectively.
- Provide expert regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, Clinical, and Marketing.
- Monitor changes in regulatory legislation, policies, and guidance documents, assessing their impact on current and future product portfolios.
- Develop and maintain comprehensive regulatory archives and databases, ensuring data integrity and accessibility.
- Participate in regulatory strategy development for new products and life cycle management of existing products.
- Review promotional and scientific materials for regulatory compliance.
- Manage and coordinate regulatory aspects of product complaints, recalls, and adverse event reporting.
Required Skills
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Life Sciences).
- Minimum of 3 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- In-depth knowledge of Health Canada regulations and guidelines (e.g., Food and Drug Regulations, GMP, ICH guidelines).
- Demonstrated experience with various submission types (e.g., NDS, ANDS, DIN, CTA, SNDS).
- Excellent written and verbal communication skills in English, with the ability to convey complex regulatory information clearly.
- Strong analytical, organizational, and problem-solving abilities.
- Meticulous attention to detail and accuracy.
- Proficiency in Microsoft Office Suite and regulatory submission software.
Preferred Qualifications
- Master's degree in Regulatory Affairs or a related field.
- Regulatory Affairs Certification (RAC) is highly desirable.
- Bilingualism (English and French) is a significant asset given the Montreal location.
- Experience with eCTD publishing software and electronic submission processes.
- Prior experience with medical devices or natural health products is a plus.
Perks & Benefits
- Competitive salary and performance-based bonus program.
- Comprehensive health, dental, and vision benefits package.
- Generous paid time off, including vacation, sick days, and holidays.
- Employer-contributed retirement savings plan.
- Opportunities for continuous learning, professional development, and career advancement.
- Supportive and collaborative work environment with a focus on innovation.
- On-site parking and access to public transportation.
- Employee assistance program (EAP).
How to Apply
Interested candidates are encouraged to submit their application by clicking the link below. Please ensure your resume and cover letter highlight your relevant experience and qualifications for this crucial role, demonstrating your expertise in Health Canada regulations.
