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Ra Pharmacist, New Products

4 months ago

Johannesburg, Gauteng, South Africa Aspen Pharma Group Full time

OBJECTIVE:


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 personnel's work and provide guidance as required.

MAIN DUTIES:

FINANCIAL

  • Effective utilization of resources to keep procedures costeffective

CUSTOMER

  • 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.

QUALITY MANAGEMENT

  • Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOP's.

DUE DILIGENCE

  • 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.

NEW REGISTRATION APPLICATIONS

  • Use Veeva RIM and dedicated Idrive 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, oversee 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

RESPONSE TO SCREENING OUTCOMES AND RECOMMENDATIONS

  • Compile and submit compliant responses to screening outcomes from regulatory authorities by requesting additional data/frills/samples
  • Oversee 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
    REGISTRATION
  • Ensure new Marketing Authorisations are up to date with all preregistration 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 postregistration variations and notify line manager of these as per process
  • Action and close out eQMS items
  • Oversee completion of administrative functions as per departmental procedures

DOSSIER MAINTENANCE (VARIATIONS)

  • 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
  • Upd