Senior Regulatory Affairs Pharmacist - Johannesburg, South Africa - Cipla

Cipla

Verified Company

Johannesburg, South Africa

2 weeks ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

_Senior Regulatory Affairs Pharmacist/Scientist_

_Based either Cape Town or Johannesburg_

Job Purpose:

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 overall objective of Cipla Medpro.

Key Accountabilities:

Accountability Cluster

Major Activities / Tasks
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CDT/New dossier submissions and approvals
Perform pre-launch activities to ensure timeous submission and registration of products within the defined timelines.

Completes dossier audits/due diligences and Regulatory Affairs (RA) strategies as required.
Complete specific preregistration 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 and in accordance with specific timelines committed to.
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 diligences and risk reports to determine gaps ahead of time, and ensure that proper steps are taken, to proactively solve challenges in the registration process. This will ensure no delay at launch stage.
Prepare new dossier submissions in paper and/or eCTD systems, as required.
Ensures timely identification of Regulatory Intelligence (RI) and appropriate impact assessment for RA and impacted departments as required. (Refer to point 5 section IV)
Dossier Life Cycle Management
Perform the dossier life cycle management activities by supporting the post registration variations and other activities to ensure support to the regulatory function and its objectives
Receive, prepare and submit all applicable updates, variations, resolutions and any other correspondence required by the SAHPRA or any other applicable regulatory authority to ensure timely delivery and as per the defined standards.
Prepare variations in paper and/or eCTD systems, as required.
Conduct dossier duediligence in support of New Business Development projects.
Support all new product launches/relaunches, which includes (but not limited to): Conducting dossier gap analysis to identify changes, artwork development, review and approval of artwork, variation preparations and submissions.
Conduct any applicable telephonic communication with SAHPRA or any other regulatory authority as part of follow up on a timely basis
Preparing postregistration updates to professional information and patient information leaflets.
Implementing any changes in regulations and advising the applicable business units.
Review and approval of all product artwork, in accordance with current Health Authority regulations and standards.
Review and approval of change control documents, as and when required.
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 (electronically and hard copies), collection and delivery of documents, ensure smooth operations and maintain quality standards
Ensure that the Document Database is kept up to date by completing the required administration activities for appropriate maintenance, coordination and accuracy of all dossiers and correspondence
Ensure correct photocopying, binding, and final preparation of documents (for submission purposes and the inhouse copy) including the quality check is timeously done before final submission to the applicable Health Authority.
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 proactively maintain critical relationships with the relevant Health authority to ensure streamlined preregistration and postregistration submissions, evaluations and registrations
Align and collaborate with relevant Cipla India based stakeholders, local stakeholders and thirdparty suppliers to ensure compliant, good quality dossiers are received to submit it to the Health Authorities.
Build and maintain relationships with all externally stakeholders, including 3rd party principals, industry bodies and consultants.
Keeping abreast of developments and changes in the local regulatory and internationa