Full-Time Director, Global Regulatory Consulting

The Position: The Director, Global Regulatory Consulting collaborates with client project teams and key decision-makers to deeply understand products, converting that knowledge into actionable regulatory strategies.

Essential Duties:

• Delivering excellent business results by partnering with clients to ensure product/service compliance with regulations.
• Acting as the primary contact, serving as project manager by breaking complex deliverables into tasks and ensuring on-time completion.
• Providing strategic regulatory considerations and paths to market for client products.
• Collaborating to understand product and goals, forming a strategy balancing risk with regulatory outcomes.
• Identifying, proposing, and directing regulatory projects, creating executable plans.
• Building/maintaining positive relationships with health authorities, negotiating during development and review processes.
• Building client relationships to generate repeat business.
• Supporting business development through sales expertise and presentation skills.
• Staying up-to-date with global regulatory requirements.
• Demonstrating commitment to Diversity, Equity, and Inclusion.
• Completing other assigned duties.

Expectations:

• Partnering with clients to meet business objectives.
• Understanding client needs and recommending regulatory strategies/tactics.
• Collaborating across functions to achieve objectives.
• Providing consultative services, ensuring positive client interactions.
• Mentoring and knowledge sharing with associates.

Minimum Qualifications:

• Bachelor's degree in a scientific discipline (advanced degree preferred).
• 10+ years of experience in Regulatory Affairs/Consulting in pharmaceutical/biotech.
• Strong regulatory knowledge (CMC, labeling, ad/promo, clinical trials).
• Proven ability to provide strategic regulatory advice.
• Experience with product development lifecycle.
• Excellent written/verbal communication, negotiation, and influencing skills.
• Strong project management skills and risk management abilities.

Preferred Qualifications:

• Master's/PhD/PharmD in a scientific/business discipline.
• Experience in various regulatory areas (e.g., CMC, ad/promo, labeling).
• Cross-functional collaboration experience.
• Global regulatory knowledge/experience.

Compensation:

Estimated base salary range: $168,000 to $235,000 (US only).

Company Culture:

• Patient-minded approach.
• Client delight focus.
• Action-oriented culture.
• Talent development.
• Collaborative environment.
• Transparent communication.
• Diversity and Inclusion.
• Innovation-driven approach.

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