Regulatory CMC Consultant - Remote

Proclinical Group; City Of London; Remote; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Regulatory CMC Contractor to lead the development of regulatory strategies for legacy dossiers, especially in injectables and foam formulations. This role involves managing complex regulatory submissions and ensuring compliance with EU procedures. The ideal candidate will possess expertise in CMC regulatory strategy and have a strong understanding of tech transfers and legacy manufacturing processes. Join a dynamic team where your contributions will significantly impact the pharmaceutical landscape, addressing regulatory challenges and driving compliance in a fast-paced environment.

Qualifications

• Expertise in regulatory submissions for injectables and foam formulations.
• Strong understanding of EU regulatory procedures and MRP.

Responsibilities

• Lead development of CMC regulatory strategies for legacy dossiers.
• Manage regulatory submissions focusing on injectables and foam formulations.

Skills

Regulatory submissions expertise

EU regulatory procedures knowledge

CMC regulatory strategy leadership

Tech transfer management

Excellent communication skills

Job description

Proclinical is seeking a Regulatory CMC Contractor to provide expertise in regulatory submissions, focusing on legacy dossiers, particularly for injectables and foam formulations. This role requires proficiency in EU procedures, including MRP and national procedures, and involves leading CMC regulatory strategy and execution for complex tech transfers and non-standard legacy manufacturing processes.

Responsibilities:

1. Lead the development and execution of CMC regulatory strategies for legacy dossiers.
2. Manage complex regulatory submissions, focusing on injectables and foam formulations.
3. Oversee tech transfers involving older dossiers and non-standard manufacturing processes.
4. Ensure compliance with EU procedures, including MRP and national procedures.
5. Collaborate with cross-functional teams to address regulatory challenges.

Key Skills and Requirements:

1. Expertise in regulatory submissions for pharmaceuticals, particularly injectables and foam formulations.
2. Strong understanding of EU regulatory procedures, including MRP and national procedures.
3. Experience in leading CMC regulatory strategy and execution.
4. Ability to manage complex tech transfers and legacy manufacturing processes.
5. Excellent communication and collaboration skills.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at [e-mail].

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. Proclinical Staffing is an equal opportunity employer.