RA Pharmacist

Matric

Bachelor of Pharmacy degree or equivalent.

Minimum 2 years experience in a Regulatory Affairs environment, including compilation and submission of new product applications and variations in accordance with the latest requirements.

1-2 years experience within the Pharmaceutical industry in a Production/Quality/Clinical environment a distinct advantage

To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the region, by ensuring successful Marketing Authorisation and variation approval from the Regulatory Authorities within the committed timeframe. The role undertakes responsibility for compliance with the Regulatory requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the Regulatory plan

Perform regulatory functions to secure Marketing Authorisation, and life-cycle management of the dossier post-registration, through effective dealings with internal and external customers and regulatory authorities

Contribute special expertise cross-functionally and provide technical and procedural training to the department and junior personnel. Peer review junior personnels work and provide guidance as required

Effective utilization of resources to keep procedures cost-effective

Display a professional attitude when responding to customers

Propose, develop and update methods to improve customer services

Effective liaison and communication with internal and external customers, including but not limited to Regulatory Authorities, External consultants and Agents, Quality Assurance, Project managers, Artwork, New Product Launches, Manufacturing Sites, Pharmacovigilance, Medical Information, AGI, APTL

Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs

Perform due diligence on new IP identified for licensing/acquisition to identify deficiencies in the IP relating to SAHPRA and SADC member states laws and regulations, in compliance with timelines in licensor/purchaser agreements

Raise all risks and critical issues with line manager at DD stage before issuing DD report

Request CCDS/PI, frills, samples, etc. from the relevant departments as per process, within specified timelines

Follow up with stakeholders on DD requests until finalization of outstanding matters, ensuring a quality and compliant submission

Use Veeva RIM and dedicated I-drive to compile quality dossiers which are compliant with country specific requirements, guidelines, regulations, and internal departmental procedures, within the allocated timelines, ensuring smooth progression to Marketing Authorisation

Raise any minor additional data requirements identified at compilation stage so as not to compromise proposed submission date

Ensure required fee is paid to the Authority

Ensure relevant support personnel are asked timeously to prepare the electronic or hard copy submission, over-see and review such activities

Ensure proof of receipt from relevant Authority is received and recorded

Update and maintain all appropriate trackers, databases and systems as required to ensure visibility and accurate reporting Attend to action items in the eQMS to ensure compliance with completion/closeout timelines

Compile and submit compliant responses to screening outcomes from regulatory authorities by requesting additional data/frills/samples

Over-see completion of administrative functions as per departmental procedures

Compile and submit compliant responses to recommendations from the following Units, being aware of communicating risks to line manager:

P&A Unit

Inspectorate Unit

Names & Scheduling Unit

P&A Variations

Marketing Authorisation Renewals

Action and close out eQMS items

Ensure new Marketing Authorisations are up to date with all pre-registration activities, including recommendations from all relevant Authority committees or units.

Ensure that all labelling components are updated with the registration details as per departmental procedures

Ensure that translated labelling text is available if required as per country specific requirements

Ensure that accurate labelling text is provided to the Artwork Department via the Pulse system, for implementation in the market

Consider impact of registration details on shared packs

Receive and review registration certificate for errors, and arrange correction

Check for post-registration variations and notify line manager of these as per process

Action and close out eQMS items

Over-see completion of administrative functions as per departmental procedures

Submit Variations to regulatory authorities in accordance with laws and regulation

Ensure the required fee is paid to the Authority

Receive and distribute approval documentation from regulatory authorities as per departmental procedures

Update and maintain all relevant trackers, databases and systems

Action and close-out eQMS items

Over-see completion of administrative functions as per departmental procedures

Coordinate and manage projects as required

Provide technical and procedural training to the department in line with development needs

Provide one on one training and coaching to less experienced staff and reviewing their work as required