Regulatory Affairs Manager
1 month ago
Experiencing together a unique human adventure
- Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.
- 1. A pharmacist, responsible to SAPC for complying with all provisions of the pharmacy act, medicines act and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist and the legislation applicable to the Virbac pharmacy which is under her personal supervision and who is registered as such in terms of the pharmacy act.
2. Responsible for RA department for RA Employees supervision, Maintenance of existing product marketing authorisations and Preparation of new submissions for registration both locally and in export countries, as well as compliance with local and foreign product regulatory submissions legislation relating to veterinary products and related activities.
Area of responsibility 1:
Main activities
1.1 LEGAL COMPLIANCE:
- Licensing requirements - DOH; SAPC; SAHPRA
- Personal accountability
- Security, control & sale of medicines
- Compliance with Pharmacy legislation & Marketing Code
1.2 HUMAN RESOURCES:
- Direct personal supervision
- Delegation letters
- Job Descriptions
- Organogram
- Appropriate knowledge & experience
- Effective GMP Training
1.3 ETHICAL CONSIDERATIONS:
- Integrity - personal, data product
- PV duties
- ADR / AE
- CPD- Reporting Company non-compliance
- Recalls
- Continuous Improvement
1.4 QUALITY MANAGEMENT SYSTEM:
- Control of manufacturing & distribution of medicines - SOP Training
- Implementation of comprehensive QMS/ PQS requirements across the Company
- Self-inspections and Audits
- Contract Giver activities
1.5 REGULATORY COMPLIANCE:
- Artwork & Labeling - Dossier submissions & maintenance - Supervision of all employed Pharmacists - Annual fees: Product, Pharmacy & Pharmacists - S5, S6 and Alcohol registers
- Launches
Expected results
Ensure that the Virbac RSA Pharmacy is duly registered with DOH, SAPC, SAHPRA and all other required registrations e.g. Company’s Act. i.e. all required certificates and licenses of the pharmacy are in place and have not expired.
Lead auditee by external auditors SAPC, SHAPRA, other.
Personally accountable for the security, control and sale of medicines.
Ensure compliance and assume legal responsibility for compliance with all legislations & that Promotion of products does not violate the applicable codes and laws in place.
Ensure continuous personal supervision of the business of Virbac RSA Pharmacy by:
Only authorized personnel have access to medicines.
All authorized personnel have Job descriptions to stipulate the duties and responsibilities in line with the work they perform.
Ensure personnel working with products are GMP Trained.
Ensure that there are systems in place to provide for personnel integrity and data integrity pertaining to products.
Ensure there is a system in place for ADR and post marketing surveillance of products and that patient safety is monitored.
Report to the authorities any illegal activities that Virbac RSA may perform that are against the Pharmacy Act and Medicines Act.
Perform mock recalls and ensure that any products released that may endanger patients and users are recalled in line with set SOPs.
Review legislation and Guidelines to ensure that Virbac processes and products are continually of high quality and standards.
Ensure that a Virbac RSA has a Quality Management system in place and that required personnel are employed and trained in QMS.
Review and approve all Master documentation e.g. Quality Manual, Validation Master Plan, Cleaning Master Plan, SOPs. Ensure that there systems in place for personnel to adhere to GxP.
Ensure there are systems in place for Internal Self-Inspections, Audits and Contracted activities.
Ensure that Virbac RSA products are manufactured and distributed in the right manner & that only approved customers receive the scheduled products.
To administer and make sure systems are in place for the regulatory compliance activities so that all Artwork, Advertising, Product Launches, Dossiers, and Scheduled substances are controlled as per the Medicines Act.
Ascertain that all employed Pharmacists and Pharmacists Assistants at Virbac RSA are duly registered with SAPC
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