Associate Director, Regulatory Affairs CMC (Biotech)

TL;DR

Associate Director, Regulatory Affairs CMC (Biotech): Leading CMC regulatory strategy and implementation for development and post-approval programs in the EMEA region with an accent on risk identification and mitigation. Focus on authoring CMC sections for regulatory submissions (IND/IMPD, NDA/MAA) and ensuring compliance with EMA, MHRA, and ICH standards.

Location: EMEA region (Remote/Hybrid options mentioned)

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Lead CMC regulatory strategy development and implementation to achieve approvals in the EMEA region.
• Plan and coordinate regulatory submissions for both development and commercial applications, including lifecycle management.
• Author CMC sections for IND/IMPD, NDA/MAA and other filings based on technical documents from Tech Operations or vendors.
• Review and approve CMC change control documents and manage the disposition of proposed changes for EMEA products.
• Provide interpretation of EMA/ICH/WHO and country-specific regulations to ensure compliance of regulatory filings.
• Collaborate with cross-functional teams to ensure objectives are met proactively and efficiently.

Requirements

• Bachelor's degree.
• 5-7 years of pharmaceutical development and regulatory CMC experience in the biotech or pharmaceutical industry.
• Solid understanding of EU/ICH regulations and country-specific guidelines for human drugs/biologics.
• Prior experience working within a GMP environment.
• Ability to interpret complex scientific issues as they relate to regulatory requirements and strategy.

Nice to have

• Knowledge of biologics and inhalation drug product development specifically within the EMEA region.

Culture & Benefits

• Flexible work schedules and hybrid-friendly technology for seamless teamwork across locations.
• Competitive retirement benefits, global equity awards, and an Employee Stock Purchase Plan (ESPP).
• Career growth via the hirify.global Learning Institute, LinkedIn Learning, and role-specific training.
• Access to AI-powered on-demand learning tools and digital assistants for internal resources.
• Global recognition programs and Employee Resource Groups.