Regulatory Affairs Pharmacist

SUMMARY:

The main purpose of this position:
 
The incumbent’s role will be to provide technical and administrative assistance to the Regulatory & QA Head, Managers and Pharmacists with regards to the registration of new medicines

Requirements:
 
Pharmacist degree & registered with the SAPC - non-negotiable
Minimum 4 years’ experience as a Regulatory Pharmacist and 1 year exposure to Quality Assurance - non-negotiable
Proficiency in one of African language is essential
Excellent written and verbal communication skills
Ability to manage multiple and varied tasks with enthusiasm and prioritizing of workload with attention to detail
 
Computer literate with good numeracy skills
A flexible attitude with respect to work assignments and new learning
Self-motivated with a willingness to accept responsibility and challenges

POSITION INFO:

Duties & Responsibilities include:
(But are not limited to)
 
General:
 
Gather information and data from multiple business partners and internal systems
Evaluate interim results and compile reports as required
Work efficiently with other regulatory personnel
Expertise regarding pharmacovigilance, quality systems in the pharmaceutical industry
Compiling a summary of technical documentation files
Create and cultivate alignment on new regulatory pathways for current and new product development in South Africa
Ensure good relations with the Regulatory Authorities and build upon a network of regulatory contacts
Ensure guidelines and regulations compliance adheres
Responsible to represent the Regulatory Function Matters at various meetings, internal and external
Implementing guidelines to support Quality Assurance''s processes
Import permits management
Responsible for Regulatory Affairs functions across the board
Responsible to obtain and maintain regulatory licenses
Review, maintain, update, compile and submit dossiers for current and new products in South Africa
Ensure to update and advise department and stakeholders on regulatory matters
Perform audits on existing and new product dossiers
Manage and ensure audit readiness at all times
Responsible for CTD / eCTD compilation, submission and follow up (non-negotiable requirement)
 

Printed Packaging / Artwork:
 
Review and approve concept of new or updated artwork/printed packaging material for medicines and related products for the SA market in compliance with applicable legislation and corporate requirements
Undertake translation and / or validation of Professional Information and Patient Information Leaflets for the SA market for new products and for existing products requiring updates to their safety information
 

Advertising & Promotional Material:
 
Review and approve all promotional material and training material relating to the advertising and promotion of medicines and related products for the SA markets in compliance with legislation, the SA Code of Marketing Practice and any other applicable regulations/guidelines and corporate requirement. This includes products marketed by other companies or licensors
Liaise with the Third-Party companies regarding appropriate promotional claims, clinical reviews etc.
Assist with the review of information relevant to each product within own portfolio
Attend promotional campaign concept presentations by the brand managers and/or advertising agencies to provide regulatory support and input to the RA Pharmacist JD marketing teams at their request
Liaise with marketing divisions and third parties where necessary regarding advice, queries, and timelines with regard to the above
 

Medicine Registration / Product Launches:
 
Assist with the sourcing of information and compilation of documentation required  for new product launches, line extensions, marketing authorization transfers,  tender applications and the like, such as Product Launch Briefs
Liaise with Third-Party companies and the New Product Launch team for information related to the completion of these documents where necessary
Obtain all relevant information and dossiers from India timeously
Liaise constantly with India on required information
Perform new product compilation in CTD and or eCTD format/do conversions
Maintain and update registrations and dossiers on existing products
Handle all technical queries properly and timeously
All relevant information and dossiers obtained from India timeously
Ensure regulatory compliance
India constantly liaised with on required information
New product compilation performed in CTD and or eCTD format/ conversions done as and when required
All screening queries handled properly and timeously
 

Project Management:
 
Assist with the management of specific projects to ensure the continued marketability of SA products when necessary
Provide any other support required for the continued commercialization of products in SA
Participate in internal audits of the HDSA-RA team and of other internal Regulatory/QA teams in accordance with the Self-Inspection schedule
 
Quality Assurance Support:
 
Provide all regulatory and QA support to SA offices
Support the compilation and maintenance of SOPS’s and GMP
Render support on all technical aspects of tenders
Strategic maintenance of Lifecycle management
Create, update and maintain status reports and trackers
Provide regulatory expertise and intelligence to all stakeholders
Reviewing of BMRs, BPRs, variation packs
Conduct & facilitate training for HDSA_RA and sales force
Release stock from distribution warehouse for sale
Support rendered on the compilation and maintenance of SOPS’s and GMP
Reviewing and approval of artwork for own portfolio
Lead or sub-lead internal, local and international audits
Perform APQRs


Should you meet the above requirements, we urge you to please apply by forwarding your CV along with any supporting documents to --------Please upload your CV here-------->
 
Contact will only be made with shortlisted candidates. Should you not hear from us within two weeks, please consider your application unsuccessful

NB! This job is now closed. You can apply for other jobs by uploading your CV.