Role Overview for Director of Regulatory Affairs
JRG Partners is actively seeking a highly strategic and experienced Director of Regulatory Affairs to join a pioneering pharmaceutical/biotechnology company at the forefront of developing groundbreaking therapies. This pivotal leadership role demands an individual with a deep understanding of global regulatory landscapes, a proven track record of successful submissions, and the ability to navigate complex scientific and regulatory challenges.
As the Director of Regulatory Affairs, you will be instrumental in shaping the regulatory strategy across the product lifecycle, from early-stage development through commercialization, ensuring that innovative medicines reach patients efficiently and in full compliance with international standards.
This is more than just a regulatory compliance role; it’s a strategic leadership position that requires foresight, meticulous planning, and exceptional communication skills. You will be responsible for building and maintaining strong relationships with health authorities worldwide, advocating for the company’s development programs, and providing expert guidance to cross-functional teams.
Your contributions will directly impact the company’s ability to bring life-changing treatments to market, making a tangible difference in global health. The ideal candidate will thrive in a fast-paced, dynamic environment, demonstrating adaptability, a proactive approach to problem-solving, and an unwavering commitment to regulatory excellence and patient safety.
We are searching for a visionary leader who can anticipate regulatory hurdles, develop innovative solutions, and inspire a team to achieve ambitious goals. This role offers a unique opportunity to lead critical initiatives, influence strategic decisions, and contribute to a culture of scientific rigor and regulatory integrity within a company dedicated to pushing the boundaries of medical science.
If you are passionate about regulatory affairs and eager to make a significant impact in the biopharmaceutical industry, we encourage you to explore this exceptional opportunity.
Key Responsibilities of Director of Regulatory Affairs
Global Regulatory Strategy Development
Formulate and execute comprehensive global regulatory strategies for product development programs, encompassing pre-clinical, clinical, manufacturing, and commercial phases. This includes identifying regulatory pathways, assessing risks, and developing mitigation plans to ensure optimal development timelines and market access.
Regulatory Submissions Management
Lead and oversee the preparation, submission, and maintenance of all regulatory applications, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and post-approval variations to health authorities such as the FDA, EMA, MHRA, Health Canada, and others. Ensure all submissions are high-quality, scientifically sound, and compliant with current regulations.
Health Authority Interactions
Serve as the primary point of contact and lead negotiator for interactions with global health authorities. This involves planning and conducting meetings, responding to inquiries, and managing ongoing communications to facilitate timely approvals and address regulatory challenges effectively.
Cross-Functional Collaboration and Guidance
Provide expert regulatory guidance, interpretation, and strategic input to internal cross-functional teams, including Research & Development, Clinical Operations, Manufacturing, Quality Assurance, Pharmacovigilance, and Commercial departments. Ensure regulatory requirements are integrated into all aspects of product development and lifecycle management.
Regulatory Compliance and Due Diligence
Ensure strict adherence to all applicable international and local regulations, guidelines, and internal Standard Operating Procedures (SOPs). Participate in due diligence activities for potential acquisitions, partnerships, or licensing opportunities, providing critical regulatory assessments and risk evaluations.
Team Leadership and Development
Recruit, mentor, and develop a high-performing team of regulatory professionals. Foster a collaborative and engaging work environment, promote continuous learning, and provide opportunities for professional growth and career advancement within the regulatory department.
Regulatory Intelligence and Landscape Monitoring
Proactively monitor, analyze, and interpret new and evolving global regulatory policies, guidelines, and legislation. Assess their potential impact on ongoing and future development programs, providing timely updates and strategic recommendations to senior leadership.
Post-Market Surveillance and Lifecycle Management
Oversee regulatory aspects of post-market activities, including adverse event reporting, product labeling updates, post-approval commitments, and responses to health authority queries related to marketed products.
Policy and Procedure Development
Develop, implement, and maintain robust regulatory policies, procedures, and training programs to ensure consistency, compliance, and efficiency across all regulatory activities within the organization.
Strategic Advocacy
Represent the company’s regulatory interests in industry associations, conferences, and working groups, contributing to the shaping of future regulatory policy and best practices.
Requirements for the Director of Regulatory Affairs
Education
Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Biotechnology). An advanced degree (MS, PharmD, PhD, JD) is highly preferred and will be a significant advantage.
Experience
A minimum of 10-15 years of progressive experience in Regulatory Affairs within the pharmaceutical, biotechnology, or medical device industry. This experience should demonstrate increasing levels of responsibility and successful outcomes in regulatory submissions and strategy.
Leadership Experience
At least 5-7 years of direct leadership and management experience, including managing teams of regulatory professionals. Proven ability to motivate, develop, and lead a high-performing team is essential.
Regulatory Expertise
Extensive and in-depth knowledge of global regulatory requirements and guidelines, particularly those of the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other major international health authorities. Thorough understanding and proven application of FDA regulations and guidelines pertaining to drug development, clinical trials, manufacturing, and post-market surveillance.
Submission Track Record
Demonstrated success in leading and achieving approval for multiple complex regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs) across various therapeutic areas. Experience with orphan drugs, biologics, or cell/gene therapies is highly desirable.
GCP, GLP, GMP Knowledge
Strong working knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations and their application in regulatory submissions and compliance activities.
Communication Skills
Exceptional written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly and concisely to diverse audiences, including senior leadership, health authorities, and scientific teams.
Strategic Thinking & Problem Solving
Proven ability to think strategically, anticipate regulatory challenges, and develop innovative, compliant solutions. Strong analytical and problem-solving skills are critical for navigating ambiguous regulatory pathways.
Collaboration & Influence
Demonstrated ability to influence, negotiate, and collaborate effectively with cross-functional teams, external partners, and health authority representatives to achieve regulatory objectives.
Certifications
Regulatory Affairs Certification (RAC) is a plus, demonstrating a commitment to professional excellence in the field.
Benefits & Perks Offered
Our client believes in investing in their employees’ well-being and professional growth. As a Director of Regulatory Affairs, you will be offered a comprehensive and competitive benefits package designed to support your health, financial security, and work-life balance. This includes:
Competitive Compensation
A highly attractive base salary commensurate with experience and a performance-based bonus structure that rewards significant contributions to the company’s success.
Comprehensive Health & Wellness
Robust medical, dental, and vision insurance plans for you and your family, ensuring access to quality healthcare. Includes options for health savings accounts (HSAs) or flexible spending accounts (FSAs).
Retirement Savings
A generous 401(k) retirement plan with a strong company match, helping you plan for your financial future.
Paid Time Off
A substantial paid time off (PTO) package, including vacation, sick leave, and company holidays, promoting a healthy work-life integration.
Professional Development
Significant opportunities for continuous learning and career advancement, including support for attending industry conferences, workshops, professional certifications (e.g., RAC), and tuition reimbursement for further education.
Flexible Work Arrangements
Potential for flexible work hours or hybrid remote options, depending on specific team and company needs, to support a balanced lifestyle.
Employee Assistance Program (EAP)
Confidential support services for a wide range of personal and work-related challenges.
Wellness Programs
Initiatives focused on physical and mental well-being, often including gym memberships or wellness stipends.
Equity/Stock Options
Depending on the company’s stage and structure, opportunities for equity or stock options, allowing you to share in the company’s long-term success.
Dynamic Culture
A collaborative, innovative, and inclusive work environment where your contributions are valued, and you have the opportunity to work alongside some of the brightest minds in the industry.
Impactful Work
The profound satisfaction of knowing your work directly contributes to bringing innovative, life-saving therapies to patients worldwide.
How to Apply
If you are a driven and experienced Director of Regulatory Affairs seeking a challenging yet rewarding opportunity to lead critical initiatives within a forward-thinking biopharmaceutical company, we encourage you to apply. This role offers the chance to make a significant impact on global health and advance your career within a supportive and innovative environment.
We invite you to learn more about this exciting opportunity and submit your application through JRG Partners, a premier executive search firm specializing in the life sciences sector. Please visit our dedicated Life Sciences Executive Search page for more details and to apply directly. Our team looks forward to reviewing your qualifications and discussing how your expertise aligns with this pivotal role. JRG Partners is committed to connecting top talent with leading organizations, and we ensure a confidential and streamlined application process.
