Senior Manager - Level 1 Regulatory Affairs CMC

This role is responsible for providing regulatory affairs expertise and support for the CMC (Chemistry, Manufacturing, and Controls) aspects of pharmaceutical products. The Senior Manager will ensure compliance with global regulatory requirements, manage submissions, and collaborate with cross-functional teams to facilitate the successful development and registration of new products.

Key Responsibilities:

Manage and oversee the preparation and submission of CMC documentation to regulatory agencies worldwide.
Provide regulatory guidance and support to cross-functional teams, including R&D, Manufacturing, and Quality Assurance.
Stay abreast of changes in global regulatory requirements and guidelines.
Develop and implement regulatory strategies to support product development and registration.
Review and approve CMC-related documents, ensuring compliance with regulatory standards.
Liaise with regulatory agencies and respond to inquiries.

Requirements/Qualifications:

Bachelor's or Master's degree in a scientific discipline (e.g., Chemistry, Pharmacy, Biology).
Minimum of 10 to 15 years of experience in regulatory affairs, with a focus on CMC.
Strong knowledge of global regulatory requirements for pharmaceutical products.
Experience in preparing and submitting CMC documentation to regulatory agencies.
Excellent communication, interpersonal, and organizational skills.
Ability to work independently and as part of a team.

About the Company:

World Courier is a global logistics company specializing in the secure and reliable transportation of high-value and time-critical shipments. They provide tailored solutions to a diverse range of industries, including pharmaceuticals, healthcare, and financial services.