Senior Director, Clinical Regulatory Affairs (Pharmaceuticals)

TL;DR

Senior Director, Clinical Regulatory Affairs (Pharmaceuticals): Leading strategic regulatory frameworks for clinical development programs with an accent on submission readiness for US and EU markets. Focus on orchestrating IND/CTA filings, mitigating clinical-regulatory risks, and managing high-level interactions with the FDA and EMA.

Company

hirify.global is a pharmaceutical company focused on clinical development and regulatory excellence in global markets.

What you will do

• Lead regulatory strategies for Phase I-III clinical programs within cross-functional global teams for US and EU markets.
• Serve as the regulatory lead for clinical submissions, including INDs, CTAs, protocol amendments, and investigator brochure updates.
• Provide strategic guidance on adaptive design, global trial harmonization, and regulatory risk mitigation.
• Coordinate the compilation of CTA/IND dossiers, PIP/SPA briefing documents, and health-authority meeting packages.
• Establish and maintain SOPs for clinical regulatory operations ensuring compliance with GCP/GMP/ICH guidelines.
• Represent the company as a senior regulatory spokesperson in interactions with regulatory agencies and external stakeholders.

Requirements

• Minimum 15 years of progressive regulatory experience in pharmaceuticals, biotechnology, or CROs.
• Proven track record leading regulatory strategy and submissions for clinical-stage products (IND/CTA) in the US and/or EU.
• Deep expertise in US FDA and EU EMA regulatory frameworks for drugs and biologics in clinical development.
• Extensive experience in global clinical trial execution, including multi-regional trials (MRCTs) and health authority negotiations.
• Bachelor of Science in Life Sciences, Pharmacy, or a related field; advanced degree (MS, PhD, PharmD) preferred.
• Ability to influence and lead within a global matrix organization.

Nice to have

• Regulatory Affairs Certification (RAC) or equivalent.