Senior Regulatory CMC Specialist

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

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Walker Cole International are currently searching for a Senior Regulatory CMC Specialist to join an exciting global consumer healthcare business with a portfolio of household name brands. This is an opportunity for somebody with mentoring experience or project & people management to progress their career. Based in Southeast England.

Your responsibilities as a Senior Regulatory CMC Specialist:

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

As a Senior Regulatory CMC Specialist, you will have:

• Expertise in Regulatory CMC strategy and authoring, module III.
• Knowledge in the regulatory requirements of post approval changes for global markets including ICH guidance
• Knowledge in handling post approval changes of Solid Oral, nasal sprays and other Dosage.
• Mentoring or line management experience.

CMC // Regulatory // Senior Specialist // Post approval // Senior Regulatory CMC Specialist // Regulatory CMC // Module 3 // OTC // Consumer Healthcare

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Consumer Services, Pharmaceutical Manufacturing, and Retail Pharmacies

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