About Company
Hiring.zycto is rapidly expanding its pharmaceutical division, seeking driven professionals to navigate the complex regulatory landscape. For a Regulatory Affairs Specialist, this means an unparalleled opportunity to shape critical health solutions, ensuring compliance and accelerating market access for innovative therapies. We foster a collaborative environment where expertise is valued, and professional growth is actively supported. Join us to be at the forefront of pharmaceutical innovation, making a tangible impact on patient lives through meticulous regulatory excellence. Your contributions directly influence our success and the broader health community.
Job Description
Hiring.zycto is seeking a highly skilled and meticulous Regulatory Affairs Specialist to join our dynamic Pharmaceutical team in Toronto. This pivotal role involves navigating the intricate web of Canadian and international pharmaceutical regulations, ensuring our innovative products meet all compliance standards from development to market launch. As a specialist, you will be instrumental in preparing, submitting, and managing regulatory dossiers, playing a crucial part in bringing life-changing therapies to patients. We are looking for a proactive individual with a deep understanding of Health Canada guidelines, ICH requirements, and a passion for upholding the highest standards of regulatory excellence. You will collaborate cross-functionally with R&D, Quality Assurance, Clinical, and Marketing teams, acting as the primary regulatory point of contact, providing strategic guidance and ensuring timely project execution. This is an an exciting opportunity to contribute significantly to a company dedicated to advancing healthcare solutions and making a real difference.
Key Responsibilities
- Prepare, review, and submit regulatory applications (e.g., DIN, NDS, SNDS, CTA, IND) to Health Canada and other relevant regulatory bodies.
- Ensure ongoing compliance with all applicable regulations, guidelines, and company procedures (e.g., ICH, GMP).
- Act as the primary liaison with regulatory agencies, responding to inquiries and managing correspondences.
- Provide strategic regulatory advice to cross-functional teams, including R&D, Clinical, and Quality Assurance, throughout the product lifecycle.
- Conduct regulatory intelligence activities to stay abreast of evolving regulatory requirements and competitive landscape.
- Manage and maintain regulatory documentation, ensuring accuracy, completeness, and accessibility.
- Review and approve promotional materials, labelling, and packaging to ensure regulatory compliance.
- Participate in audits and inspections, preparing necessary documentation and assisting with responses to findings.
Required Skills
- Proven experience in regulatory affairs within the pharmaceutical industry in Canada.
- In-depth knowledge of Health Canada regulations (e.g., Food and Drug Regulations, GMP, ICH guidelines).
- Strong understanding of the drug product lifecycle, from development to post-market surveillance.
- Excellent written and verbal communication skills for dossier preparation and agency liaison.
- Meticulous attention to detail and strong organizational skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency with regulatory submission software and document management systems.
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Life Sciences).
Preferred Qualifications
- Master's degree or PhD in a relevant scientific field.
- Regulatory Affairs Certification (RAC) from RAPS.
- Experience with global regulatory submissions (e.g., FDA, EMA) is a plus.
- Familiarity with biologics, specialty pharmaceuticals, or rare disease products.
- Project management experience in a regulatory context.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holidays.
- Retirement savings plan with company matching.
- Professional development opportunities and tuition reimbursement.
- Modern, collaborative office environment in Trillium Park, Toronto.
- Employee wellness programs and on-site fitness facilities.
- Opportunities for career growth and advancement within a rapidly expanding company.
How to Apply
Interested candidates are invited to submit their detailed resume and cover letter by clicking on the application link below. Please highlight your relevant experience in pharmaceutical regulatory affairs. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
