Regulatory Portfolio Manager

7 months ago

Centurion, South Africa Virbac Full time

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.
- Ensure availability and registration of Virbac products in RSA and other African countries, by Submission of new products; amendment of registered

products dossiers, review of artwork, review and submission of advertising materials, respond to product queries and all matters incidental thereto.

Represent Virbac in industry meetings ans or other stake holder meetings. Be availability as Pharmacist assist tutor when required. Project

management and Document management

Area of accountability # 1- Submission and Registration of new medicines in South Africa & Other African Countries

Main Activities

Accurate evaluation of source dossiers and all required documents are obtained as per regulatory authorities’ requirements. Compiled dossiers are compiled and submitted as soon as possible. Registration obtained within reasonable time period. Documentation (dossier & Correspondence) is saved and accessible in RA drive.

Expected results

New products dossiers are reviewed and correct/additional documents are requested and submitted within 1 to 3 month of receiving all correct. Follow-up on submission of dossiers is done as soon as possible and regularly to ensure timeous registration. Records of follow-up communication are kept and available. Both Word/doc & PDF Documentation are filed correctly and available of on RA/G-Drive.

Area of accountability # 2 - Maintenance of registered medicines dossiers in South Africa & Other African countries

Main Activities

Update of dossiers and package insert are submitted and Approval obtained from the authorities. Package insert are proofread and routed to relevant departments. Other departments are informed of approved changes.

Expected Results

Required dossier updates and amendments are reviewed and submitted within 1 to 3 months following receipt of all supportive data. Follow-up on submission of amendments is done as soon as possible and regularly to ensure timeous approval. Records of follow-up communication are kept and available. Both Word/doc & PDF Documentation are filed correctly and available of on RA/G-Drive

Area of accountability # 3 - Advertising/Promotional materials & Advertising SOP, review, approval & upkeep

Main Activities

Advertising SOP writing, training of relevant staff members in line with advertising legislation. Promotional materials /Advertisements are reviewed and submitted to authorities & complies with relevant legislation. Approval from authorities is obtained timeously.

Expected results

Advertising SOP is kept up to date as soon as new advertising legislation is published, within six months of publication by government. New and/or current staff are trained and training records are kept. Advertising and Promotional materials are reviewed and approved in line with Regulatory requirements within 48 hours of receipt. Act 36 & other authorities adverts are submitted within 2 weeks of internal approval. Approval by authorities is obtained timeously. (regular follow-up & records kept) Current legislation is applied for all advertising materials and no complaints from opposition companies/ regulators /users are received.

Area of accountability # 4 - RA Standard Operating Procedures & Documentation management & Product queries

Main Activities

Initiate/update allocated RA SOP’s in line with current RA requirements & train personnel. Copies of SOP’s are available to appropriate stakeholder. All RA Documents are saved and are easily retrievable. Receive and reply to product queries from sales, marketing & other VIRBAC colleagues, Regulatory authorities and or other customers as required

Expected results

Allocated RA SOP’s are initiated/updated in line with current RA requirements & Personnel trained. RA Documents are filled correctly and can be easily retrievable. RA documentation systems are implemented as soon as adopted. Applicable SOPs are up to date and comply to current legislation and guidelines. Participate in the review and or implementation of new RA system.

Area of accountability # 5 - Industry involvement, Relationship building & Legislative review

Main Activities

Attend relevant m

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