Regulatory Affairs Manager with innovative biopharma company

Would you like to become a part of innovative biopharma company with an exciting, fast-growing pipeline? Are you looking for an opportunity that will allow you to make a difference in the development of lifesaving technologies? Look no further!

My client, a high-tech, clinical stage biopharmaceutical company leading the way in the development of oncology therapeutics, is currently looking for an experienced Regulatory Affairs Manager who will play a key role in the development and execution of regulatory strategies.

Key Responsibilities:

• Ensure optimal regulatory strategies for worldwide compliance and submissions
• Author and compile FDA and EU regulatory applications and submissions
• Lead preparations for meetings with regulatory agencies
• Communicate with regulatory agencies regarding submission strategies
• Ensure regulatory documentation is maintained appropriately

Requirements:

• BSc /MSc degree with at least 2-3 years of experience in regulatory affairs
• Experience and knowledge working with oncology therapeutics
• Experience with face to face meetings with the FDA and EMA
• Ability to write scientific documents
• Knowledge of GCP and world-wide regulatory requirements relating to assigned area

For a confidential discussion please get in touch with Kate Dorsey by submitting your CV in WORD format at k.dorsey@nonstopconsulting.com