Regulatory Pharmacist - Pretoria - South Africa

Only SA Citizens need apply.

Strict screening in terms of requirements will be adhered to. Only applications with the below experience and skills will be considered.

To carry out the duties of the Responsible Pharmacist as per South African Pharmacy Council (SAPC) registration letters. The main responsibility is that of Responsible Pharmacist for the organisation in terms of the South African Pharmacy Council.

Minimum Educational Qualifications required for the job: B. Pharm Degree (Qualified Pharmacist registered with the SA Pharmacy Council).
Minimum years of Experience required for the job: 7-10 Regulatory Pharmacist Experience

DIMENSION:
The responsibilities of this job involves liaising with the manufacturers of ARV’s, Medicines Control Council during the regulatory process, handling of complex quality issues in order to satisfy Sales and Marketing, Health Care Practitioners (HCP) and other customers within the market.
Liaise and advise regulatory and packaging development personnel at the various locations on issues arising or any amendments required for labeling of products.
Regulate release of finished product following importation or local manufacture.
Ensuring the registration of organisation and maintenance of dossiers.
Functional reporting to Head of Regulatory

Regulatory
Amendments and maintenance of organsisation ARV dossiers in South Africa, Namibia and Botswana
To ensure regular contact is maintained with Medicine Control Council (MCC) units to ensure quick turnaround of critical impact amendment
To ensure the submission of amendments in CTD, timeously.
New Dossier Submission
To ensure submission of dossiers for South Africa and Namibia.
To ensure conversion of full dossier to Common Technical Document (CTD) Paper format
Releases & Manufacturing
To perform releases of finished products following Manufacturing and importation
Liaison with production QA staff
Maintain good relationships with organisation Regulatory Department Group at international head office, PDL and scientists to ensure quick turnaround time for queries on amendments and obtaining documentation for filings and amendments
Ensure that non-conformance is handled accurately within the required timeline, in consultation with the Head of Regulatory
RP Responsibilities
To carry out the duties of the Responsible Pharmacist for the organisation to include the following areas of responsibility;
To stay abreast with the Acts as amended (Medicine Act 101 of 1965 or Pharmacy Act 53 of 1974).
Submission of amendments when required to ensure compliance at all times
To review and update the Standard Operating Procedures SOPs periodically as necessary
Be responsible for Department of Health (DOH) price applications
Pharmacovigilance & Quality Complaints
To ensure understanding of the Medicines Control Council guidelines and pass assessments
Handle pharmacovigilance (PVG) complaints and refer to the relevant responsible person, PVG Manager.
Ensure that complaints are addressed and handled within the required timelines to comply with the SOPs.
Artworks and Advertising
To assist the Sales & Marketing team in screening and proof reading of marketing material and advertisements and signing-off as marketing material, so as to check regulatory and legal compliance in accordance with the act e.g. registration numbers, active ingredients and amounts, contact details of the company and grammar
Auditing
Ensure that distribution warehouse and manufacturing site audits are conducted

BEHAVIORAL COMPETENCIES:
Drive Results & Excellence
Demonstrates commitment to organizational objectives and pursues them with energy and persistence in accordance to established processes and policies. Drives accountability within team and areas of influence
Strategic Thinking
Sees connections, patterns or trends in the information available. Understands key business drivers within the organisation, the industry, and the market and identifies links between situations and information to generate profitable business opportunities and results
Collaboration & Trust
Identifies, builds and maintains strong and sustainable partnerships based on trust, with different stakeholders across teams, business units, functions and geographies to meet business objectives
Nurture Talent
Committed to development of self and others. Provides frequent and constructive feedback. Shares own knowledge and expertise to improve other’s performance and inspires them to take higher responsibilities
Customer Centricity
Reinforces the importance of being customer focused; encourages a culture that values customers while monitoring and acting on their feedback from customers. Always focuses on delivering solutions that meet customers’ need
Executive Impact / Effectiveness
Understands and articulates information shared by customers, peers and managers. Gain support and cooperation, and overcomes objections / barriers while facing difficult situations. Maintains calm, stable demeanour even under pressure or in a crisis
Leading Change
Sets the change agenda, adapts and aligns efforts and resources towards organizational goals. Shows sensitivity and respect towards diverse perspectives and cultures while driving change
Solution Orientation
Takes action to promote and implement innovative ideas. Takes initiatives and encourages innovative solutions at work by trying different and novel ways while handling work problems or opportunities.
Package: Market Related p/a TCTC

Should you not have received a response to your application within two weeks of submitting your CV, please consider your application unsuccessful. Your CV will be kept on file for any further suitable positions.