Global Regulatory Affairs Lead in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Global Regulatory Affairs Lead in United States.

This role sits at the intersection of global strategy, regulatory leadership, and cross-functional product development within a highly regulated healthcare environment. You will define and drive end-to-end global regulatory strategy across pharmaceuticals, medical devices, and consumer health products, ensuring alignment with business objectives and market expansion goals. Acting as a key liaison with health authorities worldwide, you will shape regulatory pathways, influence submissions, and ensure compliance across multiple regions. The position requires close collaboration with commercial, R&D, and leadership teams to enable successful product launches and lifecycle management. You will also play a critical role in monitoring regulatory changes and translating them into actionable business strategies. This is a high-impact leadership role with global scope, directly influencing product access and patient outcomes across international markets.

In this role, you will lead global regulatory strategy and execution while ensuring compliance, efficiency, and alignment across all markets:

• Define and drive global regulatory strategy, including submissions, labeling, lifecycle management, and change control processes.
• Serve as the primary liaison with global health authorities, managing relationships and regulatory interactions.
• Interpret regulatory guidelines and apply them to product development, submissions, and labeling strategies.
• Oversee regulatory activities across multiple regions, ensuring consistency and compliance across global markets.
• Monitor regulatory landscape changes and proactively recommend strategies to mitigate risks and ensure compliance.
• Collaborate with commercial, R&D, and cross-functional teams to support product development and market expansion.
• Provide leadership, mentorship, and strategic direction to regulatory teams and stakeholders.
• Contribute to regulatory planning, budgeting, and continuous improvement initiatives.

This position requires extensive regulatory expertise in a global, multi-market environment, along with strong leadership and strategic capabilities:

• Bachelor’s degree required; advanced degree (Master’s, PhD, PharmD) strongly preferred.
• 10+ years of experience in Regulatory Affairs or a highly regulated industry.
• Proven experience managing global regulatory portfolios across regions such as EU, AMEA, and Canada.
• Strong understanding of global regulatory frameworks, submission processes, and compliance requirements.
• Ability to interpret complex scientific and technical data and translate it into regulatory strategy.
• Demonstrated leadership skills with experience mentoring and guiding regulatory professionals.
• Strong analytical thinking, risk assessment, and decision-making capabilities in complex environments.
• Excellent communication, stakeholder management, and influencing skills across internal and external audiences.
• Strong organizational skills with the ability to manage multiple priorities and meet tight deadlines.

• Competitive base salary estimated between $165,000 and $215,000
• Eligibility for short-term and long-term incentive programs
• Comprehensive health benefits including medical, dental, and vision coverage
• 401(k) plan with company match
• Paid vacation, sick leave, and company holidays
• Disability and life insurance coverage
• Tuition reimbursement (eligible programs)
• Wellness and employee well-being programs
• Career development and leadership growth opportunities
• Inclusive workplace with equal opportunity employment practices