The Regulatory Affairs Professional located in South Africa will be appointed as the Registration Pharmacistfor the Dechra Veterinary Products SA (Pty) Ltd., Affiliate (DVP SA) and is therefore responsible to carry out all duties, tasks and responsibilities as designated by the Responsible Pharmacist (RP), (inclusive of Regulatory, Quality and Pharmacovigilance) in the absence of the RP.
The Regulatory Affairs Professional's main responsibilities are submissions, maintenance and renewals for all the products for which DVP SA is the MA holder, even if outside South Africa.
The Regulatory Affairs Professional is also responsible for any needed interactions with any Regulatory or Statutory body and 3rd parties as needed to maintain the compliance status of all the product regulatory dossiers in the affiliate.
Role ResponsibilityResponsibility 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,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 CandidateEducation and RegistrationMinimum education level: B. Pharm.Current registration in good standing with the SA Pharmacy Council as a Pharmacist.ExperienceAt 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 environmentSkills and AbilitiesHigh level of attention to detail and ability to follow detailed procedures and processes.Effective listening, verbal, and written communication skills.Excellent interpersonal skills, with the ability to communicate effectively with all levels, establishing and maintaining effective working relationships.Ability to plan, organise, and prioritise workload to meet deadlines.Professional approach to work.Ability to always maintain a high level of confidentiality and discretion.Other RequirementsSA Driver's license: Code B minimumExperience working with a globally diverse virtual team.Experience in Animal Health.Previous experience as a Registration Pharmacistin South Africa (will be an advantage).
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