Senior Regulatory Manager

Overview

• Lead regulatory activities for a pharmaceutical company, ensuring compliance with global standards and supporting product commercialization.
• Collaborate with international offices and cross-functional teams to streamline regulatory processes and submissions.
• Utilize expertise in Chemistry, Manufacturing, and Controls (CMC) for technical and hands-on regulatory tasks.
• Contribute to the development and submission of regulatory documentation for commercial-stage products.
• Engage in strategic planning to ensure regulatory readiness and compliance for global markets.
• Train and mentor team members, ensuring knowledge transfer and continuity within the regulatory department.
• Work in a hybrid environment with on-site presence required three days a week.
• Opportunity to collaborate closely with the CEO and other departments in a growing organization.

Key Responsibilities & Duties

• Manage regulatory submissions, ensuring timely and accurate documentation for global markets.
• Provide technical expertise in Chemistry, Manufacturing, and Controls (CMC) for regulatory processes.
• Collaborate with international offices in Italy and Switzerland for regulatory alignment.
• Ensure compliance with pharmaceutical regulations and standards for commercial-stage products.
• Train and support team members during transitions within the regulatory department.
• Develop and implement regulatory strategies to support product commercialization.
• Engage in hands-on regulatory tasks, including documentation preparation and submission.
• Coordinate with cross-functional teams to ensure regulatory readiness and compliance.

Job Requirements

• PhD in Chemistry or related field required for technical expertise.
• Minimum of 7 years of experience in regulatory roles within the pharmaceutical industry.
• Proven experience in Chemistry, Manufacturing, and Controls (CMC) and regulatory submissions.
• Familiarity with international regulatory standards and processes.
• Hands-on experience in regulatory tasks for commercial-stage products.
• Strong organizational and communication skills for cross-functional collaboration.
• Ability to work in a hybrid environment with on-site presence three days a week.
• Experience working with international offices preferred.