Here is an exciting pharmaceutical job one of the industry's most prestigious organisations. There is a vacancy for a Senior Regulatory Consultant to join a global top 10 pharmaceutical company at their offices located in Surrey, UK.
- To provide full product life cycle regulatory support for allocated products as required by Consumer Healthcare UK business needs
- To ensure that all allocated products are compliant with internal policies and procedures & the relevant external regulatory requirements
- To help develop and execute regulatory strategies for new OTC medicines / food supplement / medical device product opportunities
- To manage regulatory projects as required by Consumer Healthcare UK business needs
- To provide regulatory strategic support during the development of new product opportunities (Local/Global).
- To ensure compliance of allocated registered &/or non-registered OTC/ Food Supplement products with relevant regulatory requirements
- To provide ongoing regulatory support to the PCH business e.g. contributing to the development of promotional materials, regulatory review of pack copies and promotional materials.
- To participate in and represent PCH at external regulatory/technical meetings/groups as required.
- To monitor & communicate to the group changes in legislation and guidance and how they will affect current products and new product development opportunities (NPD).
- Assist internal and external customers with questions, queries and problem solving regarding products of responsibility
Skills and Requirements:
- Knowledge of UK and European Medicine licensing regulations and guidelines
- Knowledge of UK and European Food Supplement, Medical Device and Cosmetic regulations and guidelines
- Experience preparing and submitting new applications and life-cycle management (variations, renewals, etc.) in country
- Good Computer skills - Word, PowerPoint and basic Excel
- Project management skills
- Commercial awareness of pharmaceutical/OTC business
- Understanding of PAGB advertising codes
- Good knowledge and handling of RA IT systems
- Scientific Degree (advanced technical or medical/pharmaceutical degree preferred)
- At least 3 years’ experience in regulatory affairs
- Regulatory Experience with Consumer health products required (drugs and/or food supplements); Rx drugs, medical devices and cosmetics advantageous
- Experience in R&D/medical/clinical/technical areas preferred
- Regulatory experience including knowledge of regulatory requirements, application submission processes and product life cycle management activities for various consumer product categories in the country
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44 203 8718 093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.