Director – Regulatory Sciences (US Regulatory Affairs Leadership) | Remote | ProPharma Careers
About ProPharma
ProPharma is a global consulting leader with over 20 years of experience supporting pharmaceutical, biotechnology, and medical device companies. Through its advise-build-operate model, ProPharma delivers end-to-end solutions across regulatory sciences, clinical research, pharmacovigilance, quality & compliance, medical information, and R&D technology. The organization partners with clients to accelerate regulatory approvals and bring safe, effective therapies to market.
Job Overview
ProPharma is seeking an experienced Director of Regulatory Sciences to lead US-focused regulatory strategy, operations, and client delivery. This leadership role involves managing regulatory teams, overseeing submissions, and ensuring compliance with FDA and global regulatory requirements. The position requires strong expertise in regulatory affairs, strategic planning, and cross-functional collaboration within the pharmaceutical industry.
Job Location & Work Model
Work Type: Remote
Employment Type: Full-time leadership role
Key Responsibilities
Develop and execute regulatory strategies for submissions, approvals, and lifecycle maintenance aligned with business and compliance objectives
Lead, mentor, and develop a high-performing team of regulatory professionals
Oversee preparation, review, and timely submission of regulatory documents and client deliverables
Manage interactions and communications with regulatory authorities (including FDA)
Ensure compliance with global regulatory guidelines, standards, and best practices
Collaborate with cross-functional teams including R&D, Manufacturing, Quality Assurance, and Legal
Maintain strong relationships with regulatory agencies, CROs, consultants, and external partners
Provide input into departmental budgeting and resource planning
Identify, assess, and mitigate regulatory risks across programs and submissions
Ensure quality oversight across all regulatory submissions and deliverables
Required Skills and Competencies
Strong leadership and team management experience in regulatory affairs
Strategic thinking with ability to manage complex regulatory challenges
Excellent communication skills (written and verbal) for internal and external stakeholders
Strong project management and organizational capabilities
Ability to manage multiple priorities in a fast-paced environment
Deep understanding of FDA regulatory framework and submission processes
Strong collaboration skills across global, cross-functional teams
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related scientific discipline
Advanced degree (Master’s/PhD/PharmD) preferred
Experience Requirements
Minimum: 7+ years of experience in regulatory affairs within the pharmaceutical industry
Required: Proven leadership experience in regulatory strategy and operations
Strong expertise in FDA regulations, including Hatch-Waxman Act and related regulatory frameworks
Demonstrated success in regulatory submissions and approvals
Why Join ProPharma
Leadership role influencing global regulatory strategy
Opportunity to work with top-tier pharmaceutical and biotech clients
Remote flexibility with global exposure
Strong focus on innovation, compliance, and strategic impact
Inclusive and collaborative work culture
Diversity, Equity, and Inclusion
ProPharma is committed to fostering a diverse and inclusive workplace where individuals can contribute authentically and thrive. The organization promotes equal opportunity, collaboration, and innovation across all roles.
Application Process
All applications are reviewed directly by ProPharma’s recruitment team. Candidates receive transparent communication regarding outcomes. The company does not use AI-based screening tools in hiring decisions.
Important Notice
ProPharma does not accept unsolicited resumes from third-party recruiters. Direct phone calls or emails regarding this role are not permitted.
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