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SOUTH AFRICAN NUCLEAR ENERGY CORPORATION (NECSA) - REGULATORY PHARMACIST
SOUTH AFRICAN NUCLEAR ENERGY CORPORATION (NECSA)
INTERNAL/EXTERNAL ADVERTISEMENT
COMPANY: NTP Radioisotopes SOC Ltd
DIVISION: Regulatory
DEPARTMENT: Radiopharmaceuticals
VACANCY: Regulatory Pharmacist
SALARY BAND: Market-related
REF NO: EC15601
ABOUT NTP RADIOISOTOPES:
NTP Radioisotopes SOC Ltd is a subsidiary of the South African Nuclear Energy Corporation (Necsa). We are headquartered at the world-class Pelindaba nuclear facility near Pretoria, South Africa.
NTP is a leading global producer and supplier of radioisotope-based diagnostic imaging and therapy products, and exports to 50 countries around the world.
The NTP brand is built around values of excellence, safety, accountability, reliability and growth.Transformation is at the very heart of what we do at every level and we are committed to an extensive cultural change process that will enable us to ensure our world-class legacy well into the future.
As part of ensuring the sustainable, profitable future of nuclear radiation products, we have committed to systemic engagement with and improvement of our business relationships with partners and subsidiaries, and ensuring that our operating model, our leadership, and our people are supported and enabled through these processes. Enterprise Development forms a key part of our strategy for sustainability.
For more information on NTP Radioisotopes SOC Ltd visit: www.ntp.co.za
ABOUT NTP RADIOISOTOPES:
NTP Radioisotopes SOC Ltd is a subsidiary of the South African Nuclear Energy Corporation (Necsa). We are headquartered at the world-class Pelindaba nuclear facility near Pretoria, South Africa.
NTP is a leading global producer and supplier of radioisotope-based diagnostic imaging and therapy products, and exports to 50 countries around the world.
The NTP brand is built around values of excellence, safety, accountability, reliability and growth.Transformation is at the very heart of what we do at every level and we are committed to an extensive cultural change process that will enable us to ensure our world-class legacy well into the future.
As part of ensuring the sustainable, profitable future of nuclear radiation products, we have committed to systemic engagement with and improvement of our business relationships with partners and subsidiaries, and ensuring that our operating model, our leadership, and our people are supported and enabled through these processes. Enterprise Development forms a key part of our strategy for sustainability.
For more information on NTP Radioisotopes SOC Ltd visit: www.ntp.co.za
Position overview
NTP is looking for a Regulatory Pharmacist who will be accountable for providing regulatory services to NTP (to screen, request information, collate, and compile the registration dossier, pre-registration, post-registration application and where applicable any other documentation for submission to South African Health Products Regulatory Authority and other international markets). To ensure that all radiopharmaceutical products manufactured by NTP meet legislative requirements. To manage all product life cycle management within the regulatory affairs function. The role reports directly to the Responsible Pharmacist.
Job Profile:
The incumbent will be required to effectively complete all required Regulatory tasks relating to product registrations and dossier lifecycle maintenance for products NTP has regulatory responsibility and to ensure that these tasks are performed in line with SAHPRA legislation and other health authorities requirements.
KEY PERFORMANCE AREAS:
- Perform due diligence on source dossier to identify deficiencies in the dossier relating to SAHPRA regulations and requirements.
- Raise all the risks and critical issue, which will affect the planned submission date.
- Follow up with the relevant stakeholders and request any outstanding information.
- Ensure proof of receipt from SAHPRA is received and recorded.
- Responsible for all NTP registered product portfolio.
- Compilation and submission of new product applications, line extensions and/or new indications to SAHPRA and other international markets.
- Submission of Package Insert/Patient Information Leaflet updates for registered products within the required time lines in order to ensure that the product package insert contains the most recent Safety data and other relevant information.
- Life-cycle management: submission of post-registration variations and/or dossier renewals for registered products within the required time lines in order to ensure regulatory compliance in line with local Health Authority regulations.
- Submit compliant responses to screening outcomes from SAHPRA by requesting additional data or samples.
- Ensure that all marketing authorisations are up to date with all registration activities
- Maintenance of the product master files.
- Proof reading of artwork.
- Remains constantly involved with the dynamics of the regulatory affairs environment via active participation and involvement in local professional bodies.
- Ensure rapid communication to relevant colleagues in the case of changes in regulatory requirements.
- Actively participate in NTP’s efforts to access new international markets.
- Constantly monitors the regulatory environment in the respective countries by studying on draft or new regulations, guidelines, documents issued by the respective HA’s.
- Analysing complicated information including trial data.
- Offering regulatory advise about company policies, practices and systems
- Deputise for the Responsible Pharmacist
- Perform Pharmacovigilance activities
JOB REQUIREMENTS:
- Understanding and working knowledge of pharmaceuticals and the pharmaceutical industry.
- A solid understanding of the Medicines and Related Substances Act 101 of 1965 and its Regulations.
- Comprehensive knowledge of SAHPRA Guidelines.
- Knowledge of principles governing regulatory requirements such as ICH and WHO.
- Technical knowledge of the CTD and eCTD.
- Knowledge of project management principles.
- Handle multiple tasks simultaneously.
- Time management.
- Customer approach with high business understanding.
QUALIFICATIONS AND EXPERIENCE:
- Bachelor of Pharmacy Degree (B Pharm).
- Registered as a Pharmacist with Pharmacy Council.
- Experience in pharmaceutical production will be an advantage.
- Minimum of 4 years’ experience in Regulatory affairs environment, including compilation of new product application in accordance with the latest requirements.
- Minimum 2 years’ experience within the pharmaceutical industry in production and/or quality assurance environment.
Closing date: 25 June 2020.
Contact Person
Ms Fran Dos Santos
Tel: 012 305 4435
Building: Beva C4, Room 2/26, Pelindaba
Please forward or hand deliver your updated CV with certified copies of your educational torecruitment@ntp.co.za.
Important: The suitable candidate will be selected with the intention of promoting representatives and achieving EE targets as contemplated in the relevant NTP Employment Equity Plan.
GENERAL: In line with the Employment Equity Act 55 of 1998, a thorough selection process inclusive of an assessment battery will be used in order to determine whether a candidate has the necessary competencies that are inherently required to perform the role successfully.
Should you not hear from us within 30 days of the closing date, please consider your application unsuccessful.