Regulatory Affairs Manager
REPORTING LINE MANAGER
The Chief Executive Officer and the Responsible Pharmacist
1. Overall objective of Job Function
To proactively monitor, review, interpret, and translate all national regulatory requirements of the Medicines Regulatory Authority, to develop and implement strategies for earliest possible regulatory approvals to support business plans, to maintain a good standing with the local regulators and to effectively manage the regulatory department in line with the company expectations.
2. Minimum Qualification
Bachelor of Pharmacy Degree
3. Basic Competencies and minimum experience
(Knowledge, Skills & Attributes)
Must have a thorough understanding of the laws and regulations governing registration of medicines in the applicable territories. – SADC countries.
Organisational and managerial skills; problem solving; analytical skills; service orientation; decision making skills; interpersonal skills; report writing skills
Attention to detail; initiative; confidentiality; customer focused; logical thinking; information seeking; sense of urgency
>5 years experience in Regulatory Affairs with at least 2 years of managerial experience.
Detailed description of job:
(Duties & Responsibilities)
Delivery of annual product submission plan
·Compiling/overseeing submission of dossiers according to annual product submission
plan to SAHPRA and regional Medicines Regulatory Authorities within SADC
·Due diligence on prospective dossiers from India as well as other 3rd parties.
Delivery of Future Registrations.
·Continuous liaison with SAHPRA to ensure new product registrations are received on
time to satisfy the requirements of the business.
·Compile/oversee that recommendations are responded to timeously.
Life Cycle Management
·To ensure that necessary updates are made to the Registration Dossier according to
latest requirements of the MRA, including conversion of dossiers to the ZA-CTD
·To ensure timely approval of post registration amendments to avoid out of stock
·To ensure that the MRA is informed of changes to the registration dossier.
Printed Packaging Material Review
·Review for compliance with the registered dossier and final approval before print
(APLSA and third parties).
·Provide regulatory support during concept design of all new marketing material.
·Ensure compliance of all marketing material with the Marketing Code Authority and
Quality Assurance / Compliance.
·Overseeing the various activities performed by the QA pharmacist in the department.
Overseeing compliance to batch documentation review, annual product reviews, trend
analysis and overall quality risk management.
·Ensuring adherence to SAHPRA and GMP guidelines by all relevant personnel.
·SOP review and approval, creation of new SOPs as and when required.
·Vendor inspection audits when required.
·Overseeing the handling of technical product complaints and queries in accordance
with the guidelines and requirements.
·Providing feedback to the business regarding any quality issues in the Quality
Training and support
·Providing training and support to Regulatory Affairs Pharmacists and Assistants.
·Training and implementation on new SAHPRA guidelines.
·Training to sales and office personnel on Pharmacovigilance and other relevant
subjects when required.
·Liaising with India on all regulatory and quality assurance activities.
·Co-ordinating GMP/GCP inspections of parent company’s manufacturing facilities with
inspectors from the various Regulatory Authorities.
·Controlling correspondence with other pharmaceutical companies and pharmaceutical
consultants with regards to regulatory activities.
·Vendor inspection audits of distributors and laboratories.
·Finalising agreements with 3rd party contract laboratories.
·Customer relationship management with all 3rd parties mentioned above.
·Collection of adverse drug reactions and reporting it to the global Pharmacovigilance
·Providing Pharmacovigilance training and documenting these training activities.
·Provide global Pharmacovigilance with sales data and regulatory information, on request.
·Keep abreast with applicable South African laws, rules and regulations and keep global
Pharmacovigilance informed of significant developments relating to Pharmacovigilance.
·Ensuring ‘Dear Healthcare Professional’ letters are sent out in the event of urgent safety
·Overseeing that package inserts are updated to reflect the latest updated safety
Local Manufacturing technical responsibilities:
·Ensure the CMO remains GMP compliant and complies with all local legislation and
requirements as per the product dossiers.
·Ensure that all batch documentation is reviewed and releases are done appropriately
to ensure that safe and quality products are released to the public.
·To provide technical support to the CMO regarding any queries or concerns related to
any of the company’s products.
·Managing a team of Regulatory Affairs Pharmacists and Regulatory Affairs Assistants.
·Ensuring compliance to departmental targets by the various personnel of the Regulatory
·Planning and delegating of monthly targets to staff members
Reports and budgets
·Report submissions to the General Manager relating to regulatory activities of South Africa.
·Responsible for all budgets relating to the department – monthly/quarterly/annual budgets
for regulatory submissions to South Africa, as well as the general departmental budget.
·Responsible for submitting fee requisitions to the Finance department for all costs relating
to the department.
The right candidate must be experienced, goal driven and must be able to work independently.