Senior Consultant, CMC Regulatory Affairs

We are recruiting for a European based EU Biologics CMC expert / writer with a biotechnology background. It is essential you have significant experience with preparation and review of CMC regulatory documents (e.g. IMPD, M3 documents, briefing books, variations) for biologics.QualificationsSkills Required:High-level consulting skillsCritical thinking and problem-solving skillsProject leadership and management knowledgeExcellent interpersonal and intercultural communication skills, both written and verbalClient-focused approach to workResults orientationTeamwork and collaboration skillsProficiency in local language and extensive working knowledge of the English languageNetworkingBusiness analysisSelf-confidence and control

Knowledge and Experience:

Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus

Education:

Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

You will be rewarded with a competitive salary and benefits package, plus career development opportunities!