Senior Regulatory Affairs Pharmacist

4 weeks ago

Centurion, South Africa Elanco Full time

At Elanco (NYSE: ELAN) – it all starts with animals

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today

Position Description

Co-ordinates and manages the registration process and the product life cycle of all products including the compilation of dossiers for the business, while providing regulatory, scientific, medical, marketing, technical and public relations support. Support all RA Initiatives where and when required.

This role works with various Elanco departments, such as other regulatory functions, pharmacovigilance, quality, supply chain, manufacturing, business as well as with external parties like health agencies, distributors, national institutes, etc.

Functions, Duties, Tasks

Ensure compliance with regulatory requirements (timely submission of regulatory procedures including Variations, Renewals, Referrals) for existing and upcoming portfolio (Pharmaceuticals, Vaccines, Feed-Additives, Biocides)Update of the Regulatory Information Management systems (Vault RIM) and documentation repositories in agreement with regulatory management & internal procedures.Coordinate and/or conduct packaging development as part of ALRP responsibilities in the SASSA, including release of production artwork in BLUE.Contribute to the coordination of SASSA issues, submissions, packaging updates and other national tasksRegulatory review and approval of promotional materials in PromoMatsBuild and maintain good relationships with the Competent Authorities of SASSA countries, with a focus on established products. As well as keeping abreast with latest Authority legislation.Work effectively, efficiently and flexibly within and across all Elanco teams and external collaborators to achieve overall Elanco registration deliverables.Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-effective manner.Provide information to facilitate accurate and timely project and budget forecastsPerform other regulatory related duties/assignments, support SASSA Team and lead SASSA Regulatory Affairs projects on a as needed basis when required by business and directed by management

Minimum Qualification (education, experience and/or training, required certifications)

, registered with SAPC. Minimum 2 years experience in Regulatory Affairs.Good computer skills (Word, Excel, knowledge of data management)Excellent interpersonal and communication skillsStrong attention to detailGood planning and organizational skillsFluent English language

Additional Preferences

All-round RA experience new submissions, quality amendments, Artwork approvals.Open-mindedness and team player

Other Information

Maintain compliant product supply in SASSA countriesCompliance with regulatory and company requirementsLife cycle management for existing and support for new marketing authorizationsProfessional business correspondence and interaction with internal ( global Elanco, EMEA, SASSA, all functions) and external regulatory customersSuccessful cooperation and communication across countries and functionsGood Relationship with colleagues, competent authorities and associations by creating a supportive, sensitive, tolerant, constructive, respectful, friendly and open workplace environmentParticipate in creating a positive work environment and a motivating culture with a "Play to Win" mentality, in alignment with company objectivesReadiness for continuous self-development and learningAbility to set priorities and to evaluate and assess risk

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