Senior Manager, Regulatory Strategy

Job summary

The Senior Manager will design and analyze clinical trials while overseeing regulatory affairs operations to ensure compliance and quality. They will lead interactions with regulatory agencies and collaborate cross-functionally to meet global regulatory objectives.

Job details

Senior Manager, Regulatory Strategy ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Senior Manager, Regulatory Strategy at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. What You Will Do: You will oversee regulatory affairs operations, balancing quality, timelines, and stakeholder expectations. Key responsibilities include: Developing and implementing regulatory strategies for global clinical trials. Providing expertise and guidance on regulatory requirements and compliance issues. Collaborating cross-functionally with teams to ensure regulatory objectives are met. Leading interactions with regulatory agencies and preparing submissions. Keeping abreast of regulatory updates and industry trends to inform strategy. Your Profile: You will have a strong background in regulatory affairs, with proven management experience and a commitment to quality delivery. Required qualifications and experience: Bachelor's degree in a relevant scientific discipline or healthcare-related field Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry. Strong knowledge of global regulatory requirements and guidelines. Proven track record of successful regulatory submissions and interactions. Excellent communication, leadership, and problem-solving skills. Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply

What you’ll do

The Senior Manager will design and analyze clinical trials while overseeing regulatory affairs operations to ensure compliance and quality. They will lead interactions with regulatory agencies and collaborate cross-functionally to meet global regulatory objectives.

Requirements

Candidates must hold a bachelor's degree in a scientific or healthcare-related field and possess at least 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry. A proven track record of successful regulatory submissions and strong leadership skills are required.

Benefits

• Competitive base salary
• Performance related incentives
• Medical coverage
• Dental coverage
• Vision coverage
• Retirement plans
• Pension plans
• Life assurance
• Disability coverage
• Employee assistance programmes
• Wellbeing resources
• Learning and development opportunities

Listed skills

• Problem solving · Preferred
• Regulatory Compliance · Preferred
• Leadership · Preferred
• Communication · Preferred
• Project management · Preferred
• Stakeholder Management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory affairs
• Clinical trial design
• Medical data interpretation
• Regulatory strategy development
• Regulatory compliance
• Stakeholder management
• Regulatory submissions
• Leadership
• Communication
• Problem-solving
• Strategic planning
• Project management
• Regulatory Affairs
• Biotechnology
• Management
• Clinical Research
• Clinical Trials
• Innovation
• Problem Solving
• Operations
• Pharmaceuticals
• Stakeholder Management
• Balancing (Ledger/Billing)

Job areas

• Healthcare
• Management & Leadership
• Science & Research
• Consulting
• Regulatory Manager
• Regulatory Affairs Manager
• Legal Professionals Not Elsewhere Classified
• Regulatory Affairs Managers
• Managers, All Other

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