Regulatory Affairs Compliance Pharmacist (Port Elizabeth)

SUMMARY:
Pharmacist

POSITION INFO:

Description

Overview

To ensure that data and documentation generated by the manufacturing site are in accordance with worldwide regulatory standards and complies with the target market’s regulatory requirements.

 

Responsibilities

Change Management:

• Regulatory evaluation of change requests for Company South African Operations
• Advising on the variation classification and conditions to be fulfilled for the actions/ requirements to be met
• Review of submission documentation to ensure correctness and alignment with the relevant territory requirements
• Clearly and timeously communicate variation approval to the relevant stakeholders, including any conditions or timelines associated with the approval/ allowed implementation.

Data Packs Submissions:

• Provide the change classification of any variations, the conditions to be fulfilled and the actions / requirements to be met
• Assess and interpret the current registered dossier together with pending submissions / approvals
• Provide input into the Technical Project Scope Document
• Transfer of technical data packs to relevant entities to enable dossier submission ensuring support of timelines required by the business
• Review, approve and source documentation to be included in data packs to ensure all aspects are cohesively presented, and scientific justifications are included
• Compile detailed summary of changes for inclusion into data packs compiled in support of amendments to local existing products.

Regulatory Support to Third party customers

• Represent Regulatory Affairs for  South African Operations in required forums/projects
• Provide regulatory support to third party customers as per requirements
• Assist with information required for recurring renewals in territory

Regulatory Intelligence

• Provide regulatory intelligence to the site throughout all stages of the technical project s
• Interpret regulatory authority resolutions and initiate activities required in order to respond and provide feedback to internal stakeholders

Continuous improvement:

• Display continues grow and development in personal and departmental capacity.
• Present or attend regular training / awareness sessions of regulatory requirements.
• Promote diversity, equal opportunity and fair treatment in the workplace.

Quality System/ GMP / Health and Safety

• Prepare and adhere to relevant process flows and SOP’s.
• Knowledge of all Regulatory Compliance procedures, and all other procedures where Reg Compliance is a role player.
• Maintain Regulatory Compliance SOP’s, SF’s and WI’s as per quality system
• Comply with GMP requirements as outlined by company’s SOP and written instructions in all tasks and activities.
• Report any unhealthy / unsafe situations to the SHE representative or Line Manager

Requirements

Skills Required

Background/experience

• Pharm degree (registered with the Pharmacy Council)
• Minimum of 2 -3 years pharmaceutical experience

 

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

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