Job Description

We are IMETA

ROPU IMETA is a Regional Operating Unit consisting of 6 mid-sized Operating Units: India, Turkey, Southern Africa (South Africa & Sub Sahara Africa) Northeast & West Africa, Near East & UAE, Saudi Arabia, Gulf & East Africa (SAGEA).

IMETA is home to more than 47 nationalities. We are a powerhouse of talent, and we work together to ensure that we grow, nurture, and retain our talent. Uniting and working together is the key to our success.

The Opportunity

We are hiring a Technical and Regulatory Manager based in Johannesburg, South Africa. The job holder is 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 Animal Health Regulatory Affairs Manager.

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 of SAHPRA for veterinary medicines

Requirements:

• Bachelors degree in Veterinary Medicine or Bachelor in Pharmacy

• Minimum 3 years in Regulatory and Pharmacovigilance within the Pharmaceutical industry in South Africa and Sub Saharan Africa
• Registered with South African Veterinary Council or South African Pharmacy Council

Skills and Competencies:

• 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

What’s Next?

We look forward to receiving your application! We will then have a look at your profile. If we see a match, we will invite you for a screening interview.

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.

Boehringer Ingelheim is an equal opportunities employer. We value your passion to discover, invent, simplify and build. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief. We are required by law to verify your ability to work lawfully in South Africa. Boehringer Ingelheim requires that you submit a copy of either your identity document or your passport and any applicable work permit if you are a foreign national, along with an updated curriculum vitae. Boehringer Ingelheim South Africa (Pty) is strongly committed to diversity within its community and Employment Equity within the workplace, and the further diversification of ideas. In this regard, the relevant laws and principles associated with Employment Equity will be considered when appointing potential candidates.