Job title : Registration Pharmacist Job Location : Gauteng, Centurion Deadline : January 06, 2025 Quick Recommended Links Jobs by Location Job by industries Role Responsibility Responsibility as a Regulatory pharmacist for the South African and other areas in which DVP SA is the MA Holder inter alia: Ensure that all requirements with regards to any products that DVP SA is the MA holder are adhered to and met (inclusive of product batch-release when needed).
Knowledge of regulatory legislation and registration procedures for veterinary medicinal products in the target markets.
Monitoring of regulatory requirements and situation in the target markets and communication to RA leadership.
Preparation and compilation of registration submissions in accordance with the legislation of the target market.
Negotiate CMC aspects of applications and supplements to applications with the relevant Competent Authority and any other relevant regulatory agencies.
Negotiate Clinical aspects of applications and supplements to applications with the relevant Competent Authority and any other relevant regulatory agencies.
Prepare and submit any data sets required for effective and compliant promotion and ongoing maintenance of the products in the target markets.
Archiving of registration documentation in hard copy in the affiliate office and the global RA IT systems.
Contribution to strategic plans for Target Market registration activities.
Active cooperation with other RA team members and other Dechra departments (including PD) with regards to any needed local trials ensuring correct protocols followed including oversight if needed.
Active cooperation with other RA team members and Dechra departments and participation in development and refinement of processes.
Responsible for the following in support of/or in the absence of the RP: Ensuring all Legal requirements for the DVP SA Affiliate are adhered to in respect of Regulatory Requirements as a Pharmacy.
Ensure that all Personnel-related activities needed to be adhered to as the Deputy Responsible Pharmacist, including relevant legal documentation access, training and SOPs are met.
Ensure that all quality documentation, such as SOPs, quality manuals, master documents are up to date and authorised.
Ensure that periodic Product Quality Reviews are performed when needed.
Ensure proper responses to inspections/ audits by any official bodies.
The Ideal Candidate Education and Registration Minimum education level: B. Pharm.
Current registration in good standing with the SA Pharmacy Counci l as a Pharmacist.
Experience At least 5 years of pharmaceutical work experience.
Fluent in spoken and written English.
Computer literate with a working knowledge of Microsoft Office (including Word, Excel, and Outlook).
Experience working as part of a team and on own initiative.
Experience responding to queries and solving simple problems.
Maintaining manual and electronic filing systems.
Practical experience working in a busy office environment Other Requirements SA Driver's license: Code B minimum Experience working with a globally diverse virtual team.
Experience in Animal Health.
Previous experience as a Registration Pharmacist in South Africa (will be an advantage).
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