Regulatory Affairs Manager
3 weeks ago
We are seeking a Regulatory Affairs Manager working in a full-time permanent position with our client.
Reporting to the Director of Regulatory Affairs, the Manager is responsible for developing and executing regulatory strategies to achieve rapid product approvals with optimal labeling. Managing a portfolio of oncology products, this role ensures compliance with Health Canada regulations, prepares and files regulatory submissions, and builds trust with regulatory contacts to expedite approvals. Effective communication and influence across local and global functions are key, along with mentoring junior staff and interpreting Canadian regulations to align with business needs.
Responsibilities
- Regulatory Strategy Development: Formulate and implement regulatory strategies to secure rapid product approvals with optimal labeling for oncology products.
- Portfolio Management: Oversee a portfolio of oncology products, preparing, submitting, and gaining approval for regulatory documents (e.g., NDSs, SNDSs, CTAs, NCs) within stringent timelines.
- Compliance Assurance: Ensure adherence to Health Canada regulations, industry standards, and internal guidelines, aligning with organizational objectives.
- Relationship Building: Establish and maintain strong relationships with Health Canada officials to expedite submission approvals, achieve competitive labeling, and resolve regulatory issues.
- Cross-functional Collaboration: Communicate and collaborate with various local and global teams, influencing them to meet regulatory objectives effectively.
- Issue Resolution: Identify and address issues related to assigned projects or products, ensuring timely and effective solutions.
- Regulatory Interpretation: Interpret and apply Canadian regulations, guidelines, and policies to regulatory activities.
- Mentorship and Training: Mentor and train junior staff, fostering a culture of continuous learning and professional development.
- Continuous Improvement: Apply innovative and creative problem-solving techniques to enhance submission preparation and product approval processes, continuously seeking efficiencies.
- Risk Management: Act with integrity and demonstrate a strong risk management perspective, ensuring compliance and quality in all regulatory activities.
Requirements
- B.Sc. in life science or relevant scientific field (e.g., pharmacology, toxicology, chemistry)
- A minimum of 3 years of hands-on experience with innovative drug submissions & RA activities in the therapeutic area of Oncology.
- Extensive experience in Canadian regulatory affairs, leading multiple submissions at all stages of the product lifecycle
- Strong understanding of Canadian Food & Drug Regulations, guidelines, and drug development processes
- Working knowledge of global regulatory agencies and their practices
- Excellent communication, collaboration, negotiation, and project management skills
- Ability to navigate change effectively and develop strategic regulatory plans
- Proficient in using Microsoft Office applications (Word, Excel, PowerPoint, Outlook)
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