Do you wish to join a leading – edge biotechnology company who work on innovative medicines developing solutions for patients with unmet needs. Nexa Life Sciences may have the role for you!

Working as Senior Manager for Regulatory Affairs CMC you will be reporting to the Director of Regulatory. Within this role you will be pivotal in the development and implementation of regulatory strategies for CMC activities. As a Regulatory Affairs CMC Senior Manager you will be responsible for maintaining Module 3 and IMPD documentation.

Key Responsibilities Include;

• The development of CMC regulatory strategies for global regulatory requirements
• Preparation plan and leading of CMC documentation for the support of clinical trial applications including: IMPD’s, IND’s, New Drug Applications and New Product Development
• Collaboration with cross functional teams to ensure regulatory requirements are integrated efficiently and in adherence to timelines
• Provide inputs into Regulatory CMC risk assessments and migration plans
• Support regulatory authority submissions of CMC updates

Candidate Requirements Include;

• Life Sciences degree or equivalent qualification (MSc or PhD)
• Minimum 5 years’ experience in Regulatory Affairs in a pharmaceutical or biotechnology setting
• Extensive experience with the preparation of CMC sections
• Knowledge of global regulatory requirements and guidelines (EMA, FDA & MHRA)
• Outstanding interpersonal and communication skills
• Proven record of adhering to tight working deadlines
• Good combination of strategic and operational skills
• Excellent communication skills in both German & English

Should you be interested in learning more about this opportunity, please forward your up to date CV to sophie.malyon@nexalifesciences.co.uk.