Job Title: Director, Global Regulatory Affairs
Location: Chicago (Remote – Eastern or Central Time Zones Preferred)
Company: EVERSANA
Job Type: Full-Time
Salary Range: USD 180,000 – 230,000 per year
About the Company
EVERSANA is a leading global provider of integrated commercialization and regulatory solutions for the life sciences industry. With a workforce of over 7,000 professionals serving 650+ clients worldwide, EVERSANA partners with biotech, pharmaceutical, and medical device companies to accelerate product development, regulatory approvals, and market access. The organization is driven by a mission to improve patient outcomes and deliver innovative therapies globally.
Job Overview
The Director, Global Regulatory Affairs is a strategic leadership role responsible for developing and executing global regulatory strategies across the product lifecycle. This position collaborates closely with client stakeholders, regulatory authorities, and cross-functional teams to drive successful product approvals and ensure compliance with international regulatory standards. This role is ideal for experienced regulatory professionals seeking to influence global regulatory pathways, lead complex submissions, and act as a trusted advisor to clients in the pharmaceutical and biotechnology sectors.
Key Responsibilities
Develop and implement global regulatory strategies aligned with client objectives and product development goals
Provide expert regulatory guidance across clinical, CMC, labeling, and promotional domains
Lead preparation, review, and submission of regulatory documents such as INDs, CTAs, NDAs, and MAAs
Serve as a primary liaison with global health authorities including FDA and EMA
Support regulatory interactions including briefing documents, meetings, and responses to authority queries
Translate regulatory strategies into actionable project plans with defined timelines and deliverables
Collaborate cross-functionally with clinical, safety, quality, manufacturing, and commercial teams
Identify regulatory risks and provide mitigation strategies to ensure successful outcomes
Support business development activities including client presentations and proposal development
Maintain up-to-date knowledge of global regulatory requirements and evolving guidelines
Mentor and guide junior regulatory professionals within the organization
Experience Required
Minimum 10+ years of experience in Regulatory Affairs or Regulatory Consulting within the pharmaceutical or biotechnology industry
Proven track record in developing and executing global regulatory strategies
Hands-on experience with regulatory submissions and health authority interactions
Experience across multiple regulatory domains such as Clinical, CMC, Labeling, and Ad/Promo preferred
Prior consulting or client-facing experience is highly desirable
Educational Qualifications
Bachelor’s degree in a scientific discipline (required)
Advanced degree such as MSc, PhD, PharmD, or MBA (preferred)
Key Skills & Competencies
Strong expertise in global regulatory frameworks including FDA, EMA, and ICH guidelines
Excellent leadership, negotiation, and stakeholder management skills
Advanced project management and strategic planning capabilities
Strong analytical thinking and problem-solving abilities
Effective communication skills with the ability to translate complex regulatory concepts
Ability to manage multiple projects in a fast-paced, client-driven environment
Why Join EVERSANA?
Work with a globally recognized leader in life sciences commercialization and regulatory consulting
Opportunity to influence global regulatory strategies and product approvals
Collaborative, inclusive, and innovation-driven work culture
Exposure to diverse therapeutic areas and cutting-edge healthcare solutions
Strong focus on professional growth, leadership development, and career advancement
Equal Opportunity Statement
EVERSANA is an equal opportunity employer committed to diversity, equity, and inclusion. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, or other protected characteristics.
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