Senior Regulatory Affairs Pharmacist at Cipla

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

• 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 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 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 e-CTD 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.
• 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, as required.
• Conduct dossier due-diligence in support of New Business Development projects.
• Support all new product launches/re-launches, 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 post-registration 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 business with provision of dossier information, as required, e.g. documents required for tender applications
• 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, co-ordination and accuracy of all dossiers and correspondence
• Ensure correct photocopying, binding, and final preparation of documents (for submission purposes and the in-house 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 pro-actively maintain critical relationships with the relevant Health authority to ensure streamlined pre-registration and post-registration submissions, evaluations and registrations
• Engagement to include; but not limited to face to face meetings, hard copy letters, telephone calls and emails
• Tracking of pre and post registration applications with the relevant Health authority for on time and in full approvals or registrations.
• Align and collaborate with relevant Cipla India based stakeholders, local stakeholders and third-party 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 international environment which directly impacts Cipla products.  Effectively communicating these changes to all relevant stakeholders to assess the impact on the business.

Skills & Knowledge:

Educational qualifications:

• BPharm or BSc. or higher post graduate scientific degree

Relevant experience:

• 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