Regulatory Portfolio Manager
1 month ago
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 meetings & visit to authorities. Form good or meaningful relationships with opinion leaders, regulators and industry associates. Adequate contact with Internal and External stakeholders to maintain amiable & successful working relationships. Keep abreast of new legislative changes and update RA manager and or implement where applicable. Other departments are adequately informed about changes in legislation and or new requirements from authorities that impact our business.
Expected Results
Relevant meetings are attended and feedback given to RA manager & relevant colleagues. Virbac's contribution is meaningful and company positive image is maintained. Represent Virbac at appropriate associations and or working groups relevant to RA. New guidelines and legislation are reviewed and implemented as soon as they become law.
Area of accountability # 6 - Artwork and labeling materials review and approval
Main Activities
Submit correct labels and inserts with new and amendment dossiers. Submit approved labelling material to artwork coordinator as soon as approval is received from authorities. Review and approve artwork so that it complied with artwork SOP and applicable legislation and company graphic manuals.
Expected results
Correct label information is sent for review by BUM/PM before submission to authorities (New products & label/PI amendments) Approved labels & PI are saved correctly on the G Drive. & Sent to Artwork coordinator within 1 month of approval. Review and approval of artwork so that it complied with artwork SOP and applicable legislation and company graphic manuals. within 48 hours of receipt. No incorrect artwork is signed and no recalls due to artwork errors.
Area of accountability # 7 - Tutor of pharmacist assistants
Main Activities
Registration with SAPC as tutor. Mentor and guide Virbac's pharmacist assistants in line with current approved curriculum, as and when Assistants come forward for registration.
Expected results
Mentor, guide and tutor Virbac's pharmacist assistants and that the Pharmacist assistants complete the course/s successfully as per prescribed timelines.
Educational level or equivalent experience
B Pharm. or equivalent degree
Post degree training. e.g. Registration course.
SAPC registration.
Medicines & Stock remedies legislative knowledge.
Masters in Pharmacy or Science degree will be advantageous.
3 years or more in Regulatory Affairs and submission of product dossiers to authorities in RSA & other African countries.
Advanced computer literacy (G-suite, Microsoft Office Packages and other as use by Virbac).
Thorough knowledge and interpretation of Regulatory and Registration Legislation and Guidelines.
Knowledge of pharmaceutical industry.
Pharmaceutical & Pharmacology knowledge.
Clinical knowledge.
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