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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) - LEGAL REGULATORY ADVISER
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
LEGAL REGULATORY ADVISER
Ref No.: SAHPRA 018/2020
CENTRE: Pretoria
REQUIREMENTS: • An LLB or equivalent 4-year legal qualification. • At least 10 years post qualification experience in the legislative environment, opinions and general legal support. • Extensive knowledge and a proven track record in the application of the Medicines & Related Substances Act, (Act 101 of 1965). •Knowledge of Pharmacy Act, 1974 (Act 53 of 1974), Consumer Protection Act, 2008 (Act 68 of 2008), Constitution of Republic of South Africa, 1996 (Act 108 of 1996), the Labour Relation Act, 1995 (Act 66 of 1995), Promotion of Access to Information Act, 2000 (Act 2 of 2000), Promotion of Administrative Justice Act, 2000 (Act 3 of 2000). • A proven track record in Legal drafting and interpretation. •Experience in the regulatory environment / health sector will be an advantage.
COMPETENCIES/SKILLS: • Legal administration and legal practice. • Project management. Research skills. • Negotiation and dispute resolution. • Information evaluation. • Decision making. • Problem solving. • Objectivity. • Resilience. • Communication skills (verbal, written, negotiation, conflict management, presentation). •Interpretation skills. • Assertiveness. •Ethical behaviour. • Customer service. •Planning and organising skills. •Attention to detail. •Team management.
DUTIES: Legal (regulatory) Advisory Services: • Provide advice to the SAHPRA’s Chief Regulatory Officer, Head of Legal Services and Advisory Committees on health product regulatory legal matters. • Represent the CRO and CEO on legal matters in forums as delegated (ITG, PTG).and advise the CRO and CEO. • Leads and administers all appeals lodged against administrative decisions taken in terms of legislation affecting SAHPRA. •Deal with legal actions instituted against or on behalf of SAHPRA regarding regulatory matters. Regulatory Research and Reporting: • Plan and conduct research, including comparative legal research, in respect of all legislation administered by the Medicines and related substances Act. • Prepare and issue discussion papers and reports that contain research recommendations and draft legislation for law reform. • Regulatory Strategies and Operations: • Lead the perusing of laws applicable to the Regulatory environment and influence amendments to new as well as amendments to Medicines and related substances Act and related legislation. • Draft regulations for consideration by the CEO, Board and the Minister of Health. • Participate in developing regulatory guidelines and vet them for legality and conformity. • Draft legal opinions as required and administrative control duties on related legal correspondence. Management and Leadership Responsibilities: •Ensure maximal resourcing and functioning of the unit. •Manages the unit’s performance against organisational objectives. •Manages the human resources in the unit.
DUTIES: Legal (regulatory) Advisory Services: • Provide advice to the SAHPRA’s Chief Regulatory Officer, Head of Legal Services and Advisory Committees on health product regulatory legal matters. • Represent the CRO and CEO on legal matters in forums as delegated (ITG, PTG).and advise the CRO and CEO. • Leads and administers all appeals lodged against administrative decisions taken in terms of legislation affecting SAHPRA. •Deal with legal actions instituted against or on behalf of SAHPRA regarding regulatory matters. Regulatory Research and Reporting: • Plan and conduct research, including comparative legal research, in respect of all legislation administered by the Medicines and related substances Act. • Prepare and issue discussion papers and reports that contain research recommendations and draft legislation for law reform. • Regulatory Strategies and Operations: • Lead the perusing of laws applicable to the Regulatory environment and influence amendments to new as well as amendments to Medicines and related substances Act and related legislation. • Draft regulations for consideration by the CEO, Board and the Minister of Health. • Participate in developing regulatory guidelines and vet them for legality and conformity. • Draft legal opinions as required and administrative control duties on related legal correspondence. Management and Leadership Responsibilities: •Ensure maximal resourcing and functioning of the unit. •Manages the unit’s performance against organisational objectives. •Manages the human resources in the unit.
INSTRUCTIONS TO APPLICANTS: All applications must:
Be made on Z83 forms (obtainable http://www.dpsa.gov.za/dpsa2g/documents/forms/employ.pdf or from any Government department).
Be completed in full, clearly reflect the name of the position, name and date of the publication (candidates must use the post reference numbers), be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s. Applications without the afore-mentioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).
A separate application form must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.
Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated.
DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered.
Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.
It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.
Enquiries: Ms S. Molepo, Tel: +27 71 605 1508.
Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 25 May 2020 at 16H00