Regulatory Affairs Manager

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.

Tasks and 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.

Requirements:

• 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.

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.