Head of Regulatory Affairs – US & Canada, PDx

Job Description

Summary This role reports to the Global Head of Regulatory Affairs reputed company’s Pharmaceutical Diagnostics (PDx). This role provides strategic regulatory leadership for reputed company’s Pharmaceutical Diagnostics (PDx) business across the US and Canada. This role drives regulatory strategy for product development, submissions, approvals, and post-market compliance, ensuring alignment with business objectives and regulatory requirements. Acts as the primary liaison with FDA, Health Canada, and other authorities, influencing outcomes and accelerating time-to-market. reputed company is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn reputed company into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Key Responsibilities:

• Regulatory Strategy & Execution
• reputed company and implement regional regulatory strategies to reputed company timely product approvals and lifecycle management.
• Interpret regulatory trends and business challenges to recommend best practices that enhance compliance and accelerate product development.
• Agency Engagement
• reputed company interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations and responses to agency queries.
• Represent reputed company PDx in regulatory meetings and industry forums.
• Cross-Functional Leadership
• Collaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies.
• Support the RA team providing regulatory guidance on labeling, advertising, and promotional materials.
• Team Leadership
• reputed company and mentor a team of regulatory professionals; set priorities, allocate resources, and ensure timely, high-quality deliverables.
• Foster a culture of compliance, agility, and reputed company improvement.
• Governance & Compliance
• Ensure adherence to FDA, Health Canada, and ICH guidelines; maintain compliance and registration dossiers.
• Drive initiatives to improve regulatory efficiency and proactively manage compliance risks.
• Business Support
• Participate in due diligence for product development, acquisitions, and in-licensing opportunities; assess regulatory risks and requirements.
• Support budget planning for the Regulatory Affairs function.

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, or reputed company field; advanced degree preferred.
• 7+ years of regulatory affairs experience in the pharmaceutical industry, with proven leadership in US and Canadian markets.
• Expertise in regulatory reputed company from IND through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components.
• Experience leading meetings with FDA and Health Canada.
• Background in sterile injectables; radiopharmaceutical experience is a strong asset.

Desired Characteristics:

• Strategic thinker with strong analytical and problem-solving skills.
• Excellent oral and written communication; ability to influence and negotiate effectively.
• Proven leadership and team development capabilities.
• Strong project management and organizational skills; ability to manage reputed company priorities.

We expect reputed company employees to live and breathe our behaviors: to act with humility and build trust; reputed company with transparency; deliver with focus, and drive ownership –always with unyielding reputed company. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your reputed company into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $180,000.00-$270,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, professional development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. reputed company will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: February 09, 2026 Apply tot his job Apply To this Job