Senior Regulatory Affairs Associate
Pharmaceuticals Regulatory Affairs Associate Homebased and Office Opportunity: This is a great opportunity for a Regulatory Affairs (RA) Specialist to develop your career in regulatory affairs for drug products. Do you have experience in product labelling activities and regulatory drug submissions? Do you have experience of the Windsor Framework compliance? Have you compiled regulatory documents for submissions within the UK and Ireland? Looking for a contract role with an exciting global pharmaceutical company? If yes then this is the role for you. Your role as a Pharmaceuticals Regulatory Affairs Associate will involve supporting regulatory strategies for assigned product portfolios and performing life cycle management submissions for medicinal drug products. You will manage local Regulatory Affairs activities and help support business product launches and tender applications mainly for the UK and Irish markets. Duties and responsibilities include: Supporting and maintaining pharmaceutical product portfolios. Managing ongoing product information updates for Windsor Framework compliance. Supporting regulatory project plan execution. Assisting in preparation and review of labelling and local SOPs. Maintaining awareness of regulatory requirements relating to UKI regulations. Compiling regulatory documents for submission. Maintaining internal product information databases (e.g. RIM Vault) and change controls. This is a 12 months contract role which will be reviewed for a ..... full job details .....
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