[Hiring] Regulatory Consultant - CMC @Syneos Health

Role Description

The Chemistry Manufacturing Control Consultant will support the execution of multi-product global regulatory CMC for marketed products for small molecule products. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross-functional teams.

Key Duties and Responsibilities

• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on Middle East and North Africa.
• Review CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies for small molecule products.
• Work with regulatory colleagues in the development of global regulatory CMC strategies and submissions.
• Participate effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.

Qualifications

• Experience in regulatory CMC for small molecule products.
• Strong understanding of global regulatory requirements.
• Ability to work collaboratively in cross-functional teams.

Requirements

• Equivalent experience, skills, and/or education will also be considered.
• Compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate.

Benefits

• Career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Inclusive culture where you can authentically be yourself.