Beschreibung

As the Global Regulatory Lead, you will collaborate closely with the Global Product Team to shape regulatory strategies and ensure compliance throughout the product life cycle, from new registrations to ongoing management and communication with regulatory authorities.

Anforderungen

• •Completed scientific studies in Pharmacy, Biology, Chemistry, or related field
• •At least 5 years of professional experience in regulatory affairs within the pharmaceutical industry
• •Very good knowledge of regulatory laws, GMP, compliance, and CMC documents
• •Strong communication skills, including intercultural and business fluent English
• •Strong problem-solving skills and analytical thinking ability
• •Team player with performance orientation and persistence

Aufgaben

• •Serve as the primary interface with the Global Product Team
• •Shape regulatory strategies and submission plans for new registrations
• •Create high-quality documentation for registration procedures
• •Ensure compliance with internal and regulatory requirements
• •Implement regulatory activities for new registration applications
• •Lead the creation and maintenance of the Company Core Data Sheet
• •Manage inquiries from regulatory authorities
• •Implement regulatory life cycle management activities
• •Lead and coordinate regulatory projects with Merz representatives
• •Prepare for scientific consultations with regulatory authorities
• •Support the creation of benefit dossiers and health technology assessments

Benefits