Associate Director, Regional Regulatory Lead

CSL

Associate Director, Regional Regulatory Lead overseeing regulatory relationships and activities for assigned products in the biotech sector. Engaging with health authorities to drive positive regulatory outcomes.

Posted 5/6/2026full-timeKing of Prussia • Massachusetts, Pennsylvania • 🇺🇸 United StatesSenior💰 $185,000 - $210,000 per yearWebsite

About the role

Key responsibilities & impact

Accountable for assigned product relationship with a health authority (FDA or EMA)
Actively negotiates on behalf of CSL with health authority
Leads regional regulatory activities as assigned
Responsible for Module 1 documentation required for submission
Actively contribute to the GRAST activities, strategy development, document reviews and competitive regulatory intelligence
Ensures on-time execution of regulatory activities at the regional level

Requirements

What you’ll need

A bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science
An advanced degree in a related field (MS, PhD or MD, DVM) or MBA is preferred
10+ years’ experience in biotech or pharmaceutical industry, with at least 5 years of regulatory experience
Experience in leading teams (preferred 3 years)
Knowledge of pharmaceutical/biological product development and regulatory requirements for product approval in more than one key region (EU, US, Japan)
Experience working in Regulatory Affairs with direct agency interaction responsibility with at least 1 health authority.

Benefits

Comp & perks

Competitive salary
Incentive compensation
Equity options
Health insurance
Flexible work arrangements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairsModule 1 documentationregulatory intelligenceproduct approvalbiotechpharmaceutical industrypharmaceutical product developmentclinical medicinepharmacologybiology

Soft Skills

negotiationleadershipteam managementstrategic developmentcommunicationcollaborationorganizational skillsproblem-solvingcritical thinkingtime management

Certifications

bachelor's degreeadvanced degree (MS, PhD, MD, DVM, MBA)