Deputy Manager - Regulatory Affairs Pharmacist/Scientist (AA) - JHB or CPT

SUMMARY:
Support the Regulatory Affairs function in its pre-registration and/or post-registration dossier submission activities by assisting in data gathering, screening, collating, and compiling of the dossiers, post-registration variations, and any other documentation in order to submit the same to the Health Authorities for approval within the defined timelines as per the overall objective of our Client

POSITION INFO:

Job Specification

 CDT/New dossier submissions and approvals

Perform pre-launch activities to ensure timeous submission and registration of products 

Completes dossier audits/due diligence and Regulatory Affairs (RA) strategies 

Complete specific pre-registration activities including receipt, screening, compilation, and timeous submission of new dossiers, P&A, Clinical, and Naming & Scheduling responses to the Relevant Health Authority in line with the latest regulatory guidelines 

Abide by the required standards, protocols, and processes around obtaining dossiers and gathering supporting data from third-party holders after signing of supply/purchase / financial agreements

Complete any required internal due diligence and risk reports to determine gaps ahead of time 

Prepare new dossier submissions in paper and/or e-CTD systems

Ensures timely identification of Regulatory Intelligence (RI) and appropriate impact assessment for RA and impacted departments as required

Dossier Life Cycle Management- Perform the dossier life cycle management activities 

Receive, prepare and submit all applicable updates, variations, resolutions, and any other correspondence required by the SAHPRA or any other applicable regulatory authority 

Ensure compliance with the latest regulatory guidelines and prepares applications within specified timelines in order to support the business and strategic company objectives

Prepare variations in paper and/or e-CTD systems

Conduct dossier due diligence in support of New Business Development projects

Support all new product launches/re-launches, which includes 

Conduct any applicable telephonic communication with SAHPRA or any other regulatory authority 

Preparing post-registration updates to professional information and patient information leaflets

Implementing any changes in regulations and advising the applicable business units

Review and approve of all product artwork, in accordance with current Health Authority regulations and standards

Review and approve of change control documents

Support the business with the provision of the dossier information

Support the Quality Assurance teams from the various manufacturing Units with Annual Product Quality Review (APQR) requests/queries

Support and assist the administrative team in the responsibility to effectively manage and maintain dossiers 

Ensure that the Document Database is kept up to date by completing the required administration activities for appropriate maintenance, co-ordination, and accuracy of all dossiers and correspondence

Complete any internal risk reports in line with the above submissions in order to avoid rejections/comebacks from any health authority

Delivery and collection of documents from the Health Authority when necessary

Develop and manage stakeholder relationships by communicating and interacting on a regular basis in order to achieve the functional objectives

Build and pro-actively maintain critical relationships with the relevant Health authority 

Tracking of pre and post-registration applications with the relevant Health authority 

Align and collaborate with relevant Client''s India-based stakeholders, local stakeholders, and third-party suppliers to ensure compliant, good quality dossiers are received to submit it to the Health Authorities

Keeping abreast of developments and changes in the local regulatory and international environment which directly impacts Our Client products

Minimum Qualifications

AA

Candidate can be Johannesburg or Cape Town based

BPharm or BSc. Chemistry or higher post-graduate scientific degree

Minimum 2 years of experience in the regulatory function covering all areas

Attention to detail

Resilience

Collaborative approach

Time-management

Good communication skills

Team player

Experience in e-CTD submissions

Kindly note that by submitting your application for this career opportunity you agree that Guardian Recruiting may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business.

Please note that only shortlisted candidates will be contacted. Should you not have heard back within a two-week period, please assume that your application was unsuccessful.

All job postings are in accordance with our Client''s BEE requirements

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