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.
- 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
- 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 firstname.lastname@example.org
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