Regulatory Affairs Vaccines and Biologicals Senior Pharmacist. at Cipla

Job description

Purpose

To assist the RA Director to manage the Regulatory Processes related to all aspects of New Product Submissions, New Product Registrations and Life-Cycle management by ensuring high quality, timeous submissions and responses are submitted to all Health Authorities. To conduct and complete administration related to the Management of these processes for all products. This includes the RA management of processes for the Joint Venture with Teva/ Actavis and other 3rd party dossiers.

• Provides regulatory intelligence to Cipla RA Managers/ Executives/ RA Director and CEO in delivering the Cipla Vaccines and Biologicals Pipeline for submissions and registrations
• Assists the Regulatory Affairs Department Managers/ Executives and Director by providing:
• Regulatory intelligence pertaining to the current regulatory landscape and potential impact for the team and wider business related to the Cipla Vaccines and Biologicals Pipeline submission and registration for SA and SSA markets as needed.
• Up to date information on the different local and worldwide regulatory Vaccine and Biological issues and specific regulatory requirements for different geographies that Cipla is involved in
• Ensures pre-registration product submission and registration activities on time and in full:
• Helps drive the pre-registration process at each level (Product Development/ Pre- and Post- submission DDs/ MCC stage gates/ Pre-launch activities) by providing direction and guidance to ensure all milestones are achieved
• Ensuring that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly basis as per the relevant Health Authority Engagement plan and process in order to ensure first to market registrations
• Ensuring that the Regulatory Affairs Department follows the standards, protocols and processes in obtaining Cipla Vaccines and Biologicals dossiers and gathering supporting data from suppliers following signing of supply / purchase / financial agreements
• Ensuring there are processes for complete RA quality checks on all documents submitted to the MCC and or other related authorities for the Cipla Vaccines and Biologicals
• Ensures the Life cycle management / post registration and maintenance dossier activities are ensured for the Cipla Vaccines and Biologicals
• Ensuring that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly basis as per the relevant Health Authority Engagement plan and process in order to ensure first to market registrations
• Ensuring that the Regulatory Affairs Department follows the standards, protocols and processes in obtaining Cipla Vaccines and Biologicals dossiers and gathering supporting data from suppliers following signing of supply / purchase / financial agreements
• Ensuring there are processes for complete RA quality checks on all documents submitted to the MCC and or other related authorities for the Cipla Vaccines and Biologicals
• Attends and assists with the management of meetings within area of responsibility to ensure on time delivery of all objectives (bi-weekly meetings/ monthly OPCo/ Monthly Governance Deck/ RA Monthly reports/ MBR)
• Ensures on time reporting and minutes are available for the RA Director and CEO ahead of OpCO and Governance sessions for the Cipla Vaccines and Biologicals
• Ensures any gaps in RA CDT and LCM processes are identified and closed through cross functional discussions and solutions the Cipla Vaccines and Biologicals.
• Supports and enables delivery for the Regulatory Affairs Department
• Supports the Regulatory Affairs Director and Regulatory Affairs Department Management team to ensure that Cipla Medpro’s values and leadership standards are communicated and understood at all levels within the team
• Builds trust among team members by setting a highly visible example in terms of professional excellence and commitment to demonstrating Cipla values and competencies
• Participates and supports the establishment of a team culture that values, recognizes and generates high performance, supports innovation and challenges the status quo
• Participates in processes to share information and leverage initiatives across the department where appropriateSupports and encourages knowledge sharing between and or across Regulatory CDT and LCM (SA/ India/ SSA), QA, Portfolio, Medical, Project Management, Commercial, BD, etc
• Constructs and maintains RA Monthly reports from RA Tracking documents using RA electronic systems
• Develops and manages stakeholder relationships
• Identifies and develops key relationships within the Cipla South Africa Regulatory CDT and LCM (SA/ India/ SSA), QA, Portfolio, Medical, Project Management, Commercial, BD, etc
• Builds and pro-actively maintains critical relationships with the MCC and equivalent bodies in other countries to ensure streamlined submissions, evaluations and registrations
• Proactively manages relationships with the MCC’s units to ensure more effective streamlining of the company’s applications
• Assists various MCC’s committees in order to gain approval so that product registration with the Medicines Control Council can be pursue
• Engages and interacts with suppliers/ 3rd parties to explore synergies and opportunities for collaboration
• Cross Functional Integration support
• Ensures the team aligns with a matrix management approach
• Communicates company vision and service culture
• Provides input and feedback around how the function can service the business optimally
• Engages, communicates and collaborates with various internal business units (e.g. Medical, Marketing and NBD)

Education:

B Pharm or higher (post graduate) scientific degree

Experience:

5-10 years experience in a regulatory affairs covering specific Biological and Vaccines areas of the function.