Senior Regulatory CMC Lead - Global Submissions

Walker Cole International; Reading; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading consulting firm is seeking a Senior Regulatory CMC Specialist to oversee authoring and reviewing of CMC documents for a global consumer healthcare business. The ideal candidate will have strong regulatory strategy expertise, mentoring experience, and be able to manage global submissions. This is a full-time role based in Southeast England offering a great opportunity for career progression.

Qualifications

• Expertise in Regulatory CMC strategy and authoring, module III.
• Knowledge in handling post approval changes of Solid Oral, nasal sprays and other Dosage.
• Mentoring or line management experience.

Responsibilities

• Oversee the authoring and reviewing of CMC documents and global submissions.
• Act as global/regional CMC representative in cross-functional team projects.
• Lead the preparation of CMC information for submission to global regulatory agencies.

Skills

Regulatory CMC strategy

Project management

Mentoring

Knowledge of post approval changes

Job description

A leading consulting firm is seeking a Senior Regulatory CMC Specialist to oversee authoring and reviewing of CMC documents for a global consumer healthcare business. The ideal candidate will have strong regulatory strategy expertise, mentoring experience, and be able to manage global submissions. This is a full-time role based in Southeast England offering a great opportunity for career progression.