Senior Regulatory Affairs Manager – CMC, Bio/Vax

This is a fully remote position, open to applicants in United Kingdom, +8 more countries.

📋 Description

• Compose CMC sections and scientific rationales for regulatory submissions and responses.

• Develop and execute strategies for variations in accordance with EU guidelines.

• Oversee CMC activities across various projects.

• Collaborate with global affiliates and manufacturing facilities.

• Offer project leadership and management.

• Ensure satisfaction of clients and maintain project quality.

• Identify potential business opportunities and assist in proposal development.

• Engage in a client-focused project without the responsibility of managing personnel.

⛳️ Requirements

• More than 10 years of experience in regulatory affairs.

• Comprehensive knowledge of CMC writing and strategies for variations.

• Practical understanding of vaccines or biological processes is essential.

• Experience interacting with regulatory bodies (e.g., FDA, EMA, MHRA).

• Profound knowledge of EU guidelines (Variation, ICH, EMA).

• Exceptional project management and organizational skills.

• Strong communication skills and experience in client management.

• Capability to work independently as well as collaboratively within a team.

• Proficiency in English, both written and spoken.

• Proficiency in additional languages is an advantage.

🏝️ Benefits

• Flexible working arrangement, either from home or the office.

• Opportunity to engage in a variety of projects.

• Experience in a global pharmaceutical setting.

• Involvement in client-specific projects.

• Proficiency in additional languages is a plus.