Regulatory Affairs Pharmacist - Variations at Aspen Pharma Group

MAIN DUTIES:

FINANCIAL

•  Effective utilization of resources to keep procedures cost effective.

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 and Compliance, 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 secure 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 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.

RESPONSE TO SCREENING OUTCOMES AND RECOMMENDATIONS

• 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 Authority Units (including renewals), being aware of communicating risks to line manager.
• Action and close out eQMS items

REGISTRATION

• 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.

DOSSIER MAINTENANCE (VARIATIONS)

• Submit Variations to regulatory authorities in accordance with laws and regulation.
• Ensure 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.

PROJECTS

• Coordinate and manage projects as required.

TRAINING

• 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.

QUALIFICATION AND EXPERIENCE:

• Matric
• Bachelor of Pharmacy degree or equivalent
• Registered with the South African Pharmacy Council as a practicing Pharmacist.
• 1 to 2 years’ experience within the Pharmaceutical Industry in a Production/Quality/Clinical environment.
• Minimum 2 years’ experience in a Regulatory Affairs environment, including compilation and submission of variations and new products in accordance with the latest regulatory authority requirements.