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Job Overview:

We are seeking an experienced and visionary Head of Regulatory Affairs to lead our global regulatory strategy in clinical development. The ideal candidate will have a deep understanding of regulatory requirements, particularly in FDA and CDE submissions, and a proven track record of success in BLA, NDA, Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), Fast Track Designation, and other critical regulatory milestones. This leadership role requires strategic oversight, strong regulatory expertise, and the ability to influence decision-making at all levels, ensuring our clinical development programs are aligned with regulatory expectations and drive forward our company's goals.

Key Responsibilities:

· Regulatory Leadership: Lead and shape the regulatory strategy for all clinical development programs globally, ensuring timely submissions and approval of new therapies. Serve as the primary liaison with regulatory agencies (FDA, EMA, etc.).

· Regulatory Strategy Development: Develop and execute global regulatory strategies for the clinical development of new drugs and biologics, ensuring alignment with business objectives and industry best practices.

· FDA and CDE Expertise: Oversee all FDA and CDE regulatory activities, including IND, BLA, NDA, and other filings, ensuring full compliance with regulatory guidelines and accelerating approval timelines.

· Designations Management: Lead efforts to obtain Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), Fast Track status, and other relevant designations to facilitate the development and approval of novel therapeutics.

· Regulatory Submissions: Oversee the preparation, review, and submission of regulatory dossiers, clinical trial applications, and other documents for regulatory review. Ensure high-quality, compliant, and timely submissions.

· Cross-Functional Leadership: Collaborate with senior leadership and cross-functional teams (Clinical Development, Medical Affairs, Legal, Manufacturing, and Commercial) to develop regulatory strategies that support clinical development and product commercialization.

· Agency Interactions: Build and maintain strong relationships with regulatory authorities and manage interactions with the FDA, EMA, and other global health agencies. Provide leadership during regulatory meetings, responding to agency questions and feedback.

· Regulatory Risk Management: Proactively identify regulatory risks and provide strategic guidance to mitigate risks across clinical development programs. Ensure that contingency plans are in place to address regulatory hurdles.

· Team Leadership: Lead and develop a high-performing team of regulatory affairs professionals, providing mentorship, guidance, and support. Foster a culture of excellence, continuous improvement, and accountability within the team.

· Regulatory Intelligence: Keep the organization informed of global regulatory trends, changes in guidelines, and emerging opportunities, ensuring that the company remains compliant and competitive.

· Regulatory Compliance: Ensure that all clinical trials and regulatory submissions adhere to GxP, ICH, and other relevant global regulatory requirements and industry standards.

· Performance Monitoring: Monitor the progress of regulatory activities and provide regular updates to senior management, ensuring that key milestones are met within the specified timelines.

Qualifications:

· Education: Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, or a related field. An advanced degree (MS, PhD, or equivalent) in regulatory affairs, pharmacology, or related discipline is preferred.

· Experience:

o Minimum of 10 years of experience in Regulatory Affairs with a focus on global clinical development within the pharmaceutical or biotechnology industry.

o Significant experience with FDA regulations and CDE submissions is required, with a strong understanding of the IND, BLA, NDA submission processes.

o Proven success in obtaining Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), Fast Track status, and other regulatory designations.

o Demonstrated leadership experience in managing cross-functional teams and influencing senior stakeholders.

o Comprehensive understanding of global regulatory requirements (FDA, EMA, ICH, and other agencies), especially in relation to clinical trials, regulatory submissions, and product approvals.

· Skills:

o Strong strategic thinking and problem-solving abilities, with the capacity to manage complex regulatory challenges.

o Excellent communication and interpersonal skills, with the ability to influence and build relationships with global regulatory agencies and internal teams.

o Expertise in regulatory submission management tools and electronic submission platforms (e.g., eCTD).

o Ability to mentor and lead a team, fostering a culture of collaboration, growth, and high performance.

o Exceptional organizational and project management skills, with a proven ability to handle multiple projects simultaneously in a fast-paced environment.

Preferred Skills:

· Regulatory Affairs Certification is a plus.

· Experience with global regulatory submissions and approval processes across various regions, including the US, EU, Japan, and other emerging markets.

· Previous experience in biologics and advanced therapies is highly desirable.