Regulatory Affairs Pharmacist at Ascendis Health

Job description

MAIN PURPOSE:

• To create, update, submit and maintain product dossier registration documentation in   accordance with the applicable regulations which includes translating regulatory requirements into practical, workable submission plans and to develop and maintain timelines.
• To provide thoughtful and accurate comments during document review mindful of regulatory requirements.
• To write clear, accessible product labels, patient information leaflets and package inserts.
• To collect all the information/specifications required for dossier compilation.
• To finalise and present to the RP a completed dossier in the required format for final approval.
• To acquire published new or amended acts, regulations, bills and notices relevant to the pharmaceutical industry.
• To supply technical information and registration support to the relevant departments and identify deviations from legislation and recommend corrective action.
• To develop and maintain current regulatory knowledge.
• To identify SOP’s or specifications that are affected by new or amended legislation.
• To perform regulatory audits on Ascendis Consumer brands products.
• To ensure that Quality standards are maintained during dossier creation and propose improvements.
• To collect technical information relating to finished products during new product development (NPD) and to be part of the NPD process.
• To initiate and facilitate change control requests and forward to QA Pharmacist.
• Without detracting from specific tasks and duties referred to in the job description, required to comply with any reasonable requests or instructions from the Head of Regulatory related to company functions from time to time.