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Registration Pharmacist
1 month ago
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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 Council 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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