Together with our client, in the pharmaceutical industry, we are recruiting for a Regulatory Affairs / Deputy Responsible Pharmacist to join their team in Meyersdal, Johannesburg. The ideal candidate must have a BPharm with at least 3 years Regulatory Affairs experience preferred (Regulatory Affairs, Dossier Submission to SAHPRA. Exposure to production would be an advantage.
Delivery of New Product Submission Plan
- Submission of new dossiers as per the annual product submission plan to SAHPRA and MRA’s of other designated territories according to the latest guidelines.
- Ensure the screening application is submitted within the stipulated time frame from the date of receipt of the dossier from the company.
Delivery of Future Registrations
- Continuous liaison with SAHPRA to ensure new product registrations are received on time to satisfy the requirements of the business.
- Compilation of responses to all allocated SAHPRA pre-registration recommendations within a stipulated time frame.
- Physical and electronic superseding of the dossier with pre-registration responses.
Life Cycle Management
- To ensure that necessary variations are made to the Registration Dossier according to latest requirement of the MRA.
- To ensure timely submission and approval of variations.
- To ensure that the MRA is informed of changes to the registration dossier.
- To ensure the company is made aware of any approvals, queries and rejections from SAHPRA regarding any variations.
Printed Packaging Material (PPM) Development and Control
- Review of all PPM for launch products.
- Assist in the maintenance of all PPM’s and implementation of any regulatory changes to PPM’s as required.
- To ensure PPM development and approval within stipulated timeline to ensure no delays in launch.
- Review of promotional material against the Marketing Code.
- To evaluate the Regulatory impact of change controls.
- Assisting the Responsible Pharmacist with Pharmacovigilance related activities below as and when required.
- Collection of adverse event and drug safety data and reporting/forwarding it to the global pharmacovigilance department within 4 calendar days of receipt of the ADR.
- Submission of individual case reports to the South African regulatory authority in a timeous manner, and record keeping.
- Providing pharmacovigilance training and documenting these training activities.
- Completing and forwarding a monthly pharmacovigilance compliance report to global pharmacovigilance department (Report to include new product authorizations with dates; new products launched; product withdrawals, with dates and reason for withdrawal, product licenses dropped due to reasons other than safety).
- Provide global pharmacovigilance department with sales data and regulatory information, on request.
- Keep abreast with applicable South African laws, rules and regulations and keep global pharmacovigilance department informed of significant developments relating to pharmacovigilance
In the absence of the Responsible Pharmacist, the Deputy Responsible Pharmacist contemplated in regulation 25 (3) of the Pharmacy Act and the relevant sections of the Medicines Act shall:
- Ensure that he/she in fact continuously supervises the company.
- Have appropriate qualifications and experience in the services being rendered by the company.
- Ensure that persons being employed by and who provide services forming part of the scope of pharmacy practice of a pharmacist are appropriately registered with the Pharmacy Council.
- Notify the Pharmacy Council immediately upon receiving knowledge that his/her services as responsible pharmacist have been or will be terminated.
- Take corrective measures in respect of deficiencies with regard to inspection reports of the Pharmacy Council or in terms of the Medicines Act.
In addition to the general responsibilities also –
- Ensure that unauthorized persons do not obtain access to medicines or scheduled substance or the pharmacy premises outside of normal trading hours;
- Establish policies and procedures for the employees of the pharmacy with regard to the acts performed and services provided in the pharmacy;
- Ensure the safe and effective storage and keeping of medicine or scheduled substance in the pharmacy under his or her direct personal supervision.
- Have the overall responsibility for release of the finished products to the market;
- Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances;
- Initiate and coordinate all recall activities which should involve the Quality Assurance Pharmacist;
- Compile a letter of delegation of authority in her/his absence;
- Control the manufacturing or distribution of medicines, scheduled substance or medical devices in terms of the provisions of the Medicines Act, 1965;
- Ensure that there is compliance with Good Pharmacy Practice as published by the Pharmacy Council;
- Be part of the decision-making process affecting the pharmacy business;
- Ensure that the pharmacy owner complies with all conditions of ownership of such pharmacy business as well as registration of the pharmacy
- Ensure that no person is appointed to perform any act falling outside the scope of practice of the category in which such person is registered ow which he/she is not authorized to perform in terms of the Pharmacy Act, 1974 (Act 53 of 1974);
- Report in writing any non-compliance with the Pharmacy Act to the management of such pharmacy business and furnish Pharmacy Council with a copy thereof;
- Not introduce or carry out any instruction or order of management with regard to the pharmacy business of the pharmacy owner which could amount to a contravention of legislation applicable to such pharmacy business
- Be responsible to the South African Health Products Regulatory Authority (SAHPRA) for compliance with the provisions of the Medicines and Related Substance Act, 1965 (Act 101 of 1965) relating to the scale, control of the manufacturing and distribution of medicines, scheduled substance or medical devices
- BPharm Degree
- 3 Years Regulatory Affairs experience
- Exposure to Production will be an advantage
- Market related (based on experience and qualification)
If you are interested in the above-mentioned position, please send your CV with REF: Deputy Responsible Pharmacist to firstname.lastname@example.org or email@example.com We can also be contacted on 012 755 3779