Pharmacist

SUMMARY:
Pharmacist

POSITION INFO:

Our client , a well established company is currently looking for a Pharmacist to join their team.

Registration of new products:
Works in collaboration with the Corporate Head Responsible Pharmacist to proactively assess local submissions requirements, review & sign-off content for registration packages accordingly.
Conducts dossier due diligence to ensure all data gaps are addressed in preparation for new registration applications.
Legislation, Regulatory Authorities & Process Improvement:
Keeps abreast of new developments in legislation, guidelines, and regulations of the NMRAs, interprets and cascades these locally and globally within the organization.
Liaises with the NMRAs and appointed Agencies on new developments in the registration process, and ongoing activities for registered products.
Communicates approvals from health authorities to relevant stakeholders.
Identifies and recommends opportunities for improvement to the existing processes, quality, systems, tools, and policies.
Maintains written procedures are up-to-date.
Maintaining existing registrations:
Prepares and submits technical updates based on the review of current data versus data contained in the registration application.
Compiles and submits technical amendments based on requests and data received from the registered manufacturing site and I or the RPL.
Reviews and approves new artwork and updates to artwork in line with regulatory requirements to be uploaded to the artwork system by RA associate.
Compiles and submits renewal packages for countries where this is required within the agreed timelines to ensure no loss of registration license.
Reviews and approves promotional material for marketed products to ensure compliance with the relevant product registration and any country-specific Code of Marketing Compliance.
Liaising internally and with other departments:
Business Development, Quality Assurance, Medical, Pharmacovigilance, Sales & Marketing, Operations.
Management of quality documents relating to Regulatory Affairs processes:
Ensures compliance to EPD Global & Regional RA Quality Systems, policies, and procedures.

KEY SKILLS

Detailed understanding and knowledge of dosage requirements and administration, chemical compounds, and pharmaceutical brands.
Working knowledge of Microsoft Office Suite and software applications, used by pharmacies, such as MEDITECH and Mediware.
Great organizational skills.
Excellent verbal and written communication skills.

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