Senior Regulatory Affairs, Career development in biotech!

Location
Homeworking
Salary
Negotiable
Posted
Jan 10, 2021
Closes
Feb 10, 2021
Ref
KD274420.2
Contact
Kathryn Dorsey
Organization Type
Corporate
Contract Type
Employee
Hours
Full Time

Are you looking for a position that will allow your voice to be heard and to actually make a difference? Are looking for something that offers exciting career progress with a fast-growing company? Then look no further!

My client is an innovative, late clinical-stage nanomedicine company leading in the development of novel radiotherapy techniques for oncology treatments. This exciting and fast growing company is currently looking for an experienced Senior US Regulatory Manager who will play a key role in the development and execution of regulatory strategies

Key Responsibilities:

  • Ensure that all regulatory submission are high quality and meet requirements
  • Interface with FDA and other regulatory agencies
  • Help develop regulatory strategy for submissions and registrations and work with product development teams
  • Keep up to date with regulatory changes, manage and coordinate regulatory intelligence to ensure company compliance

Requirements:

  • Bachelor's degree in a scientific discipline, higher degrees and Regulatory Affairs Certification preferred
  • Provide advice about regulations to manufacturers/ scientists
  • Plan, undertake and oversee product trials and regulatory inspections
  • A minimum of 5-7 years of regulatory experience in drug development, biotechnology field or pharmaceutical industry
  • Experience with FDA regulatory submissions and meetings

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

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