For more than 130 years, Boehringer Ingelheim has been committed to the research, development, and manufacturing of new medications with high therapeutic value for people and animals. As a family-owned pharmaceutical company, Boehringer Ingelheim is able to take a long-term view and invest heavily in research and development. We are proud of addressing some ...
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We are looking for a Technical and Regulatory Manager based in Johannesburg. This position will be responsible for driving internal and external regulatory compliance for registration and maintenance of Boehringer Ingelheim Animal Health products and ensuring promotional materials are following legislation and relevant codex. Key responsibilities in this role will include ensuring pharmacovigilance and compliance in line with legal and company requirements and providing technical support for assigned products. This position will be reporting to the Head of Animal Health South Africa.
Tasks & Responsibilities:
Ensure timely submission and completion of dossiers to achieve successful registration of new veterinary products in line with local regulatory requirements
Maintain registration of registered products by providing updates, variations and renewals through timetables and timely payments
Oversee, check and approve advertising and promotional materials are in compliance with relevant laws, regulation and codex
Ensure appropriate pharmacovigilance reporting to internal and external functions through system maintenance and technical product knowledge
Participate and contribute to relevant stakeholder meetings to establish state of the art internal and external regulatory network and knowledge
Support in registration of new products and registration maintenance for additional Sub-Saharan countries in line with respective portfolio strategies
Ensure correct and accurate artwork of veterinary packaging that is compliant with the regulatory requirements of the South African and SSA Regulatory Authorities
Provide technical support for assigned products by providing timely response to customer requests, technical advice and competent trainings
Closely collaborate with Quality Control with respect to legal and regulatory requirements for veterinary medicines
Requirements:
Bachelors degree on Veterinary Medicine or Pharmaceutics
Minimum 3 years in Regulatory and PV within the Pharmaceutical industry in South Africa and Sub Saharan Africa
Prior experience in handling and managing projects
Strong scientific and technical knowledge
Ability to balance an understanding of the business and customer needs
Flexibility and agility to manage and support changes in the organization and need for continuous improvements
Excellent interpersonal and communication skills
Capable of organizing, planning, and prioritizing workload
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