Pro4orm People Ltd have partnered with a scaling and innovative global pharmaceutical company. Our client is devoted to delivering high value products to healthcare professionals, the NHS and patients. Our client offers a fast paced environment and opportunity for development as they continue to grow.
We are looking for an experienced Regulatory Affairs officer to join our client’s team based in Leicester. It would suit someone with a minimal of 1 years’ experience looking for a company who is passionate about employee development.
This role is perfect for someone who is a team player, with great organisational skills and the ability to work well under pressure. Someone who wants to work a wide variety of projects and different markets.
Key Responsibilities:
* Submission, maintenance and control of regulatory information and documentation for medicines, medical devices, and other products
* Internal and external liaison - Act as first point of contact for third parties (e.g. contract manufacturers/research organisations), regulatory agencies and internal departments for specific issues relating to products.
* Due diligence - Assist with regulatory due diligence of new products using knowledge of current regulations and guidance.
* Project management - Understand and manage workload for assigned projects in line with business priorities
* Compliance - Maintain awareness of existing and new legislation/guidance relating to EU, UK and RoW (as required) GxP; Medicines; Medical Devices including all ISO activities (including ISO13485 and ISO14971); Controlled Drugs; Nutritional Products; In Vitro Diagnostic Devices; Biocidal Products; and General Data Protection Regulations and the UK Data Protection Act, as required.
* Regulatory Intelligence - Maintain awareness of new and existing legislation and guidance from regulatory competent authorities.
Requirements
* Proven 1 – 2 years regulatory experience
* Degree in scientific or similar discipline
* Highly organised with good attention to detail
* Can work on a hybrid model (3 days in the office and 2 days working from home)
Pro4orm People Ltd is acting as an Employment Agency in relation to this vacancy. Pro4orm People Ltd is an Equal Opportunities Employer. Due to a high volume of applications we will only be able to contact successful applicants within 5 working days. We may, however, contact you regarding other potential roles of interest. By applying for this position you will be agreeing to our Terms and Conditions, and Privacy Policy which can be found on our website www.pro4ormpeople.com
Equal Opportunity Employer:
At Pro4orm People Ltd we are committed to fostering an inclusive and diverse workplace. We welcome applications from all qualified candidates regardless of race, gender, sexual orientation, religion, disability, or background.