Regulatory Affairs and Quality Executive
4 weeks ago
Contract type: Permanent
The Head of North American Compliance is a highly visable, strategic and hands-on role. The individual in this role will be responsible for the day-to-day oversight and operations of Compliance activities in the US and Canada, as well as developing a Compliance plan for the organization with measurable metrics.
Designing, implementing, overseeing, and enforcing business rules to ensure compliance with relevant laws, regulations, and industry standards.
Leading team of Compliance professionals in ensuring the elements of an effective compliance program are met, including implementing necessary policies and procedures, ensuring effective training, ensuring a robust auditing and monitoring program is in place, and investigating/responding promptly to detected problems.
Evaluating the Compliance function to ensure capacity and competencies to support the organization's growth trajectory.
Collaborating with Global counterparts to ensure synergies between Region North America and Global Compliance programs.
Serving as a strategic business partner providing proactive Compliance support to designated business areas across the Region.
Contributing to the budget planning process by developing plans to support compliance business strategy, financials and organizational structure.
Chairing and managing Canadian Compliance Committee Meetings.
Providing Compliance review of materials submitted for Legal/Medical/Regulatory (LMR) committee review.
Subject matter expert with respect to privacy for LEO Pharma Canada and local Data Protection Focal Point.
Conduct risk assessment on marketing strategies and communicate to management appropriately and in a timely manner.
Ensure timely escalation of all potential Compliance issues to Vice President, North America Legal & Compliance.
Lead and assist with internal investigations related to violations of internal policies or the LEO Code of Conduct, as necessary.
Ensure compliance with appropriate SOP's, policies and guidelines applicable to role.
Complete mandatory training in assigned timelines upon hire as well as when new or revised policies, SOP's, guidance's are issued.
Participate in personal development and training sessions as required for the position.
Report any health or safety concerns (internal and external) in compliance with LEO Pharma policy and standard procedures.
Execute other duties as may be required by Executive team members and other members of LEO Pharma's Management team as training and experience allow.
8+ years in a senior-level Compliance role in Canada or the US.
Food and Drug regulatory policies for the pharmaceutical industries
Decision Quality
At LEO Pharma's Thrombosis Business Unit, we are dedicated to making a global impact in the fight against thrombosis. With over 8 million patients treated annually, we understand the significance of addressing this critical medical need and strive to improve patient outcomes.
We value diversity and believe that different perspectives, backgrounds, and attitudes contribute to making the best decisions.
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