Job Description
Senior Regulatory Affairs Manager Warman O'Brien are searching for a Senior Regulatory Affairs Manager for a globally renowned pharmaceutical business that manufactures Generic products in the UK. The role has arisen due to an increase in workload as the team looks to expand in the UK. This is a hybrid role with an expectation of 2-3 days per week in office. Senior Regulatory Affairs Manager - Responsibilities Compiling, preparing and submitting relevant components of the dossier Leading relevant agency interactions (EMA and MHRA) Defining and executing Regulatory strategy Ensuring products remain compliant with relevant legislation License maintenance activities including renewals and variations of existing licenses Leading Market Authorisation Application submissions Mentoring junior employees accordingly Senior Regulatory Affairs Manager - Requirements 7+ years of pharmaceutical Regulatory Affairs experience Experienced with small molecule, respiratory products Experience leading submissions for Generic products (MAA, Variations, Renewals) Experience maintaining Centralised European licenses Experience maintaining UK licenses A team player, with a positive and can do attitude Please note, you must possess a valid right to work in the UK to be considered for this role.
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Senior Regulatory Affairs Manager Warman O'Brien are searching for a Senior Regulatory Affairs Manager for a globally renowned pharmaceutical business that manufactures Generic products in the UK. The role has arisen due to an increase in workload as the team looks to expand in the UK. This is a hybrid role with an expectation of 2-3 days per week in office. Senior Regulatory Affairs Manager - Responsibilities Compiling, preparing and submitting relevant components of the dossier Leading relevant agency interactions (EMA and MHRA) Defining and executing Regulatory strategy Ensuring products remain compliant with relevant legislation License maintenance activities including renewals and variations of existing licenses Leading Market Authorisation Application submissions Mentoring junior employees accordingly Senior Regulatory Affairs Manager - Requirements 7+ years of pharmaceutical Regulatory Affairs experience Experienced with small molecule, respiratory products Experience leading submissions for Generic products (MAA, Variations, Renewals) Experience maintaining Centralised European licenses Experience maintaining UK licenses A team player, with a positive and can do attitude Please note, you must possess a valid right to work in the UK to be considered for this role.
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