Technical & Regulatory Manager

1 month ago

Randburg, South Africa BI AH ZA (Proprietary)Ltd Full time

**THE POSITION**:
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 trainingsClosely 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 skillsCapable of organizing, planning, and prioritizing workload**What happens Next?**

**Screening**:
In order to comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (“SPL”). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its Affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.

At Boehringer Ingelheim we share the opinion that diversity and inclusion is essential for the growth of our business and that our strengths and competitive advantage are also the result of the diversity of our company - diversity across the three dimensions of inclusion: Gender, Geography and Generation. Our people are part of a deep-rooted, family company philosophy that welcomes everyone We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity or national origin.

**Join this exciting team to contribute & develop your own path

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