On-Demand Interim Regulatory Support for Life Sciences Organizations
The life sciences environment is changing rapidly. It’s tougher than ever for pharmaceutical companies to keep pace with constantly-evolving regulatory requirements and shrinking submission timeframes. These factors exert ongoing pressure on companies of all sizes – from growing market leaders up to the largest, most established organizations.
Klein Hersh is the trusted partner for pharmaceutical and biotech companies seeking experienced regulatory professionals for interim roles across regulatory strategy, CMC, labeling, advertising and promotional review, and operations. Our talent network includes industry veterans and established consultants who bring specialized expertise and the ability to integrate seamlessly into your organization to accelerate critical submissions, meet regulatory milestones, and provide the flexible staffing solutions you need to stay competitive in today’s fast-paced regulatory environment.
With major milestones on the horizon, and new ones emerging in real time, regulatory teams often require specialized external resources to meet critical deadlines in your drug development life cycles and manage peak demand. Klein Hersh can address your pressing functional needs and seamlessly augment your team by providing access to experienced regulatory affairs consulting professionals on an interim staffing basis.
Executive Regulatory Consulting Specialists
Klein Hersh has dedicated experts with the drive to address your pressing functional needs and seamlessly augment your team by providing access to experienced regulatory professionals on a contract basis. We know your industry because it’s our industry too. With an average tenure of 10+ years, our team is deeply immersed in the regulatory space. Always available and dedicated to your success, we move with precision and collaboration at every step.
How Are We Different from Other Regulatory Consultant Search Firms?
Klein Hersh is ideally suited to meet your regulatory consulting and interim staffing needs. With over 25 years of combined experience cultivating far-reaching regulatory talent networks, we “recruit ahead of the need” and build lifelong relationships. Listening to each individual’s motivations and understanding your organization’s interim staffing needs accelerates our ability to identify your next interim leader.
Helping Clients Who Need Risk and Regulatory Consulting Assistance
Klein Hersh leverages our best asset – our unmatched talent network – to efficiently and cost-effectively deliver the high-caliber interim talent you need to bridge the gap during staff changes, ensure critical projects stay on track, and enable organizational growth. Klein Hersh can even assemble entire teams to tackle complex, longer-term regulatory requirements, while also providing support for multiple staffing assignments across product development life cycles.
Trust Klein Hersh to connect you with interim regulatory professionals who can support your development programs and address requirements in key areas including:
Regulatory Affairs Consulting
Organizations frequently need experienced regulatory professionals to support submission preparation and health authority interactions. These roles span regulatory strategy development, filing preparation, and agency communication management. Klein Hersh connects organizations with regulatory experts who bring relevant submission experience and can quickly integrate into regulatory teams to maintain critical timelines.
Regulatory Consulting CMC
Pharmaceutical and biotech companies regularly require CMC regulatory support for development programs and commercial products. Klein Hersh identifies experienced CMC professionals who understand regulatory requirements across development phases and can guide CMC strategy and documentation. These specialists provide strategic and tactical support while maintaining flexibility in resource planning.
Product Labeling
Klein Hersh connects organizations with labeling specialists who bring extensive experience in developing and maintaining compliant labeling. Our network includes professionals with expertise in global labeling requirements, health authority negotiations, and lifecycle management. These experts step in to manage both routine updates and complex labeling projects.
Advertising and Promotional Reviews
Organizations need experienced regulatory professionals to ensure compliant promotional materials across therapeutic areas and product types. Klein Hersh identifies specialists with demonstrated expertise in promotional review committees and health authority requirements. These professionals provide consistent review coverage while supporting peaks in promotional activity.
Regulatory Strategy and Operations
Klein Hersh connects organizations with regulatory operations professionals who bring extensive experience in submission management and regulatory information systems. Our network includes specialists in electronic submissions, publishing, and regulatory documentation who can support both routine filings and complex applications.
Why Partner with Klein Hersh?
Klein Hersh provides strategic solutions for organizations requiring interim regulatory support:
- Rapid access to experienced professionals, including former regulatory affairs leaders, CMC specialists, and submission managers who understand pharmaceutical and biotech development
- Flexible staffing solutions to manage increased workload in regulatory affairs, CMC, and labeling without long-term commitments
- Quick deployment of qualified specialists for time-sensitive submissions and unexpected staffing needs
- Cost-effective alternatives to full-time hiring for specialized regulatory roles and finite project durations
- Seamless integration of interim professionals who bring both technical expertise and operational experience in similar organizations
- Support for critical regulatory initiatives during organizational transitions
- Access to regulatory leaders with specific therapeutic area expertise and health authority experience
- Strategic guidance from experienced professionals who have successfully navigated similar regulatory challenges
To learn more about our interim staffing and consulting services, please contact:
