LiCa Scientific is hiring for a pharmaceutical contract research/manufacturing organisation in the North East for a member of their regulatory affairs team.
What you’ll do
This role will work in a team based environment in a mid sized, established business. We’re looking for someone who can cover a broad range of regulatory roles, however important to stress it’s a team effort. If you have a less experience under your belt but an awareness, understanding and desire to work in regulatory affairs in CMC and GMP, you’re welcome to apply.
We are seeking someone to cover their Chemistry Manufacturing Controls and Good Manufacturing Practice related regulatory activity of a client. The company works in pharmaceutical API research producing active pharmaceutical ingredients and final products for clinical trials. The role will involve on a day to day basis working on regulatory information for submissions or responses to enquiries.
Duties will involve:
• Coordinate, produce and review CMC regulatory documentation for submission to global regulatory agencies. This may include documentation required at all clinical phases and include the provision of radiolabelled submissions to enable AME studies
• Provide guidance to clients on what CMC regulatory information is required for their specific project
• Prepare responses to questions received following submission of a regulatory dossier
• Assist in the coordination of quality document streams across the centre as required
We are seeking a candidate that possesses some or all of: extensive knowledge and experience of CMC regulatory documentation, awareness of the drug development process, full awareness of M7 ICH guidance for potentially mutagenic species, good written and oral communication skills, flexible approach to new work challenges. You will be a graduate or equivalent and able to commit to a 6 months temporary contract commencing in September 2016.
LiCa Scientific is acting as an employment agency/or business on this occasion.