Overview
Regulatory Affairs Manager Jobs in Johannesburg at BI South Africa (Pty)Ltd
THE OPPORTUNITY
We are hiring a Regulatory Affairs Manager responsible for the management and execution of regulatory activities for South Africa . The job holder performs quality regulatory activities in compliance with internal and external requirements to support business continuity.
The job holder will be based in Johannesburg, South Africa and will report to the Head of Regulatory Affairs.
Responsibilities
Timely execution and management of local Regulatory Affairs activities in compliance with Regional RA strategies and local business priorities.
Maintain product registrations and RA databases while ensuring business continuity in compliance with internal and external regulations and requirements.
Collaborate with local health authorities to support Boehringer Ingelheim’s business (Human Pharma) in the operating unit
Provide regular intelligence on changes in regulatory environment, competitor activity and opportunities to enable the business realize risk or opportunities arising in the RA environment.
Participate in budget exercises and collaborate cross-functionally and ensure all stakeholders are updated on relevant RA topics.
Establish a strong partnership and interact with the local authorities in the country; Maintain efficient relationships with related Regulatory service Providers (local agents and vendors).
Conduct agreed actions for local projects.
Provide support to the country RA head on local, regional and global projects.
Required Capabilities
Bachelors in Pharmacy / Masters is an advantage
4 – 6 years Regulatory experience in a multi-national Pharmaceutical company; Human Pharma experience preferred.
Significant experience of direct interactions with Regulatory Authorities.
People management experience is an asset.
Regional or International working experience is a plus.
Skills:
Strong business acumen and operational excellence
Innovative and critical thinking
Effective negotiation skills
Demonstration of effective cross-functional collaboration
Problem solving and Decision making
Project management
Good Presentation skills
Time management
Our differences are our strengths. A global collective. Waiting for you.
What’s Next?
We are looking 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.
Diversity & Inclusion @ Boehringer Ingelheim
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.
Title: Regulatory Affairs Manager
Company: BI South Africa (Pty)Ltd
Location: Johannesburg
