Pharmacy Compliance

8 months ago

Brampton, Canada Pillway Full time

**Overview**:
Pillway is seeking a dedicated Pharmacy Compliance & Regulatory Affairs Officer to lead our compliance efforts across Canada. Ideal for a self-motivated and autonomous professional, this role demands excellence in adhering to and exceeding the standards of NAPRA and provincial regulations. The chosen individual will be essential in performing audits, developing compliance strategies, and handling the regulatory nuances of virtual/mail-order pharmacy operations, ensuring Pillway maintains the highest compliance standards and fosters strong regulatory relationships.

**Key Responsibilities**:

- Compliance Strategy and Policy Development: Craft and implement comprehensive compliance strategies and policies tailored to the virtual/mail-order pharmacy sector, ensuring alignment with NAPRA guidelines and provincial regulations.
- Documentation and Submission: Oversee the preparation, review, and submission of all regulatory documentation required by Health Canada and other relevant authorities.
- Compliance Assurance: Ensure ongoing compliance with all regulatory requirements, keeping abreast of legislative changes that impact the pharmaceutical industry.
- Regulatory Liaison: Act as the primary contact for regulatory authorities, managing communications and negotiations to address any regulatory concerns.
- Internal Collaboration: Work closely with departments such as R&D, quality assurance, and marketing to integrate regulatory considerations into product development and lifecycle management.
- Regulatory Intelligence: Maintain an up-to-date understanding of national compliance trends, focusing particularly on the challenges faced by virtual/mail-order pharmacy models.
- Stakeholder Engagement: Serve as the principal liaison with regulatory authorities, portraying Pillway’s compliance efforts in a positive light.
- Audit Collaboration: Collaborate with pharmacists to facilitate external audit processes, ensuring adherence to regulatory standards.
- Risk Management: Identify, evaluate, and mitigate compliance risks, ensuring proactive management of potential regulatory issues.
- Pan-Canadian Expansion Oversight: Strategize and implement compliance frameworks for new market entries, ensuring regulatory cohesion across provinces.
- Compliance and Regulatory Training: Develop and lead comprehensive training programs, promoting a culture of compliance and regulatory excellence within Pillway.

**Qualifications**:

- Educational Requirement: A degree in Pharmacy from a Canadian institution, accompanied by licensure and professional practice within Canada. Advanced degrees or certifications in regulatory affairs (e.g., Regulatory Affairs Certification) are highly desirable.
- Regulatory Expertise: A strong background in compliance and regulatory affairs within the pharmacy sector, with comprehensive knowledge of the Canadian regulatory environment, including Health Canada and NAPRA guidelines, especially pertaining to virtual/mail-order pharmacies.
- Analytical Proficiency: Outstanding analytical skills, with a keen eye for detail in audit processes and a commitment to evidence-based decision-making.
- Communicative Excellence: Exceptional communication and negotiation skills, capable of managing intricate discussions with both internal teams and external regulatory bodies with professionalism and diplomacy.
- Autonomous Operation: Proven ability to work independently, displaying integrity and professionalism.
- Adaptability and Flexibility: Ready to adapt to a dynamic work setting, which includes remote work, occasional office visits, and travel for audit purposes.
- Risk Management Skills: Demonstrated ability in identifying and managing regulatory risks.
- Training and Development: Experience in creating and delivering compliance training programs.

**Why Work With Pillway?**:
Joining Pillway means becoming part of a pioneering team dedicated to revolutionizing digital pharmacy in Canada. Here's why you should consider us:

- ** Competitive Benefits and Compensation**: We offer market-aligned salaries, comprehensive health benefits, and the potential for participation in our Employee Stock Option Plan over time.
- ** Flexible Work Environment**: Our culture thrives on flexibility, allowing you to balance work and personal life seamlessly.
- ** Inclusive and Dynamic Culture**: Be part of a great workplace culture that values diversity, innovation, and teamwork.

**Interview Process**:

- ** Cross-Functional Team Interview**: Engage with various team members across the organization to ensure a mutual fit.

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