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Senior Regulatory Affairs – SASSA Alliance
Eli Lilly and CompanyGauteng, South Africa16 hours ago
Job descriptionExecuting the Regulatory Plan to ensure the success of new product registration, line extensions and new indications in alignment with the SASSA Alliance business plan, while maintaining compliance for all products with local regulations and quality system requirements. Foster an environment of operational excellence and collaborate with cross-functional teams to successfully achieve the SASSA Alliance regulatory objectives. Facilitate and cultivate relationships with relevant external regulatory personnel and the local regulatory agencies / MoH’s in the region. Partner Oversight : Provide operational excellence to support submission plans, assist to monitor progress and provide Lilly support as necessary Dossier Management : Support timely provision of required submission documents to the Partners as per agreed submission plans. Maintain data in Lilly systems and electronic archives. Support labelling projects to ensure new and updated printed packaging materials are available in line with timelines agreed with the Partner. Bachelor’s degree in Pharmacy. Registration with the South African Pharmacy Council. Tertiary course in Medicine Registration an advantage. At least one year industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs. Team working skills with special focus on results. Ability to adapt to challenging situations. Demonstrated good computer / IT skills. Good knowledge of written and spoken English. Analytical, problem solving and negotiation skills. Strong planning and priority setting. Good capability to establish positive networking both internally and externally. Strong knowledge of quality systems. Knowledge of current legislation governing product registration. Knowledge of other legal requirements impacting the regulatory / quality environment i.e. advertising, trade and metrology, foodstuffs and cosmetics, GMP, GLP, GCP, GDP, GPP, etc. Knowledge of pharmacology and therapeutics. Implement the Regulatory Plan in alignment with affiliate business plans as well as regulatory requirements. Ensure submission and approval of high quality regulatory applications within planned timelines. Maintain or support maintenance of clear metrics for Regulatory deliverables. Preparation and support of new applications to obtain marketing authorisations. Voicing affiliate perspective and needs to global and regional regulatory contacts. Ensuring timely responses to requests from support groups and / or Regulatory Authorities. Maintaining marketing authorisations (timely submission of post approval maintenance activities like renewals, variations and periodic reports). Maintain Regulatory Tools in alignment with defined compliance metrics. Support Affiliate launch Teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plans. Represent the Regulatory Affairs function as appropriate in Affiliate Lead Team and New Product Planning discussions. Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally. Facilitate interactions with regulatory bodies on a regular basis. Ensure that internal Regulatory IT tools are up to date and accurate. Ensure that all products comply with local regulations and quality system requirements whichever is more stringent. Ensure that the regulatory archive is complete and up-to-date and that all current licenses and labels are readily available. Ensure implementation of local quality system in line with the global quality system and local regulations. Support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel. Implement corrective / preventive actions as appropriate. Provide regulatory quality oversight for Third Parties (i.e. Regulatory Services Providers, Translators, Graphic Agencies, etc.) as appropriate. Raise awareness of leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions. Perform the function of Primary, Alternate or Delegate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and Lilly Core Data Sheet Follow global labelling procedures and document relevant exceptions to produce accurate and high-quality Product Information in compliance with global core labelling. Liaise with the SASSA Alliance Labelling Co-Ordinator to support the creation of labelling projects in BLUE and liaise with Supply Chain and PPD to ensure new / revised labelling available in line with Partner’s timelines Support & ensure alignment and implementation of internal regulatory initiatives. Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge. Support implementation of launch readiness initiatives. Build and maintain relationships with key regulatory officials (External Influence). Assist with affiliate training and education on regulatory matters and provide regulatory input to local strategic initiatives. Knowledge and understanding of local regulations and local, regional and global regulatory procedures. Attend appropriate external symposia, workshops or conferences to develop technical expertise
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
PURPOSE
- The purpose of the Senior Regulatory Affairs – SASSA Alliance (P2) role is to execute the operational aspects of regulatory affairs and / or regulatory support on Lilly’s behalf for the SASSA Alliance or for the strategic business partners who are Marketing Authorization Holders for Lilly products in the SASSA region.
This includes :
Countries in scope : South Africa, Benin, Botswana, Burkina Faso, Burundi, Cabo Verde, Cameroon, Central African Republic (CAR), Chad, Comoros, Congo, Democratic Republic of the Congo (DRC), Djibouti, Equatorial Guinea, Eritrea, Eswatini (Swaziland), Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, Swaziland, Tanzania, Togo, Uganda, Zambia, Zimbabwe.
Qualification & Experience
Key Responsibilities
Regulatory Plan Execution
Regulatory Compliance
Labelling
Process Improvement
Personal and Professional Development
Additional Pertinent Information
The candidate chosen for this position will be employed through a Labour Broker, SAFRIMED, which is a third-party partner organization located in South Africa. They will work exclusively for Eli Lilly, providing dedicated support to the business goals. The contract is open-ended and does not have a set end date.
Application Process
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Senior Regulatory • Gauteng, South Africa
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