Regulatory Consultant - CMC - Remote

Overview

The Regulatory Consultant - CMC will support the execution of multi-product global regulatory CMC for marketed small molecule products, contributing to the preparation and submission of regulatory CMC documentation.

In Short

• Support execution of global regulatory CMC for marketed products.
• Prepare and submit regulatory CMC documentation.
• Work with cross-functional teams.
• Execute commercial Lifecycle Management strategy.
• Review CMC sections of regulatory submissions.
• Serve as primary regulatory CMC contact for assigned products.
• Collaborate with regulatory colleagues on global strategies.
• Drive impact for customers in the biopharmaceutical industry.
• Engage in career development and progression.
• Participate in an inclusive culture.

Requirements

• Experience in regulatory affairs.
• Knowledge of Chemistry Manufacturing Control.
• Understanding of CMC documentation processes.
• Ability to work in cross-functional teams.
• Strong communication skills.
• Experience with small molecule products.
• Familiarity with commercial lifecycle management.
• Problem-solving mindset.
• Ability to navigate regulatory complexities.
• Commitment to inclusivity and collaboration.

Benefits

• Career development opportunities.
• Supportive and engaged management.
• Technical and therapeutic area training.
• Peer recognition and rewards program.
• Inclusive company culture.
• Collaboration with diverse teams.
• Access to comprehensive resources.
• Work-life balance initiatives.
• Impactful work that improves patients' lives.
• Opportunity to shape the future of healthcare.