Regulatory Management Specialist

3 weeks ago

Modderfontein, South Africa Merck KGaA Darmstadt Germany Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginablewith us.

**Your Role**:
A new role has opened up and we are hiring a regulatory management specialist to be based in Johannesburg.

You will act as the in-country Regulatory Representative in South Africa and will also give the regulatory support to other English-Speaking African Countries strategic for the Life Science business (LS). You will be responsible from the effective management of regulatory support for LS products and services such as scheduled substances, APIs, ABPs (Antibodies, Recombinant proteins, Cell Culture Media etc.), In-Vitro Diagnostics, Medical Devices, Food additives etc.

Build up leadership initiatives for relationship with local authorities and industry associations as per the company's interest. Be responsible from advocacy and surveillance activities with local governmental authorities and associations.

Monitor and report on changes of relevant regulatory and compliance environment with impact to the company's commercial activities. Analyze available regulatory and compliance information.

You will also ensure effective coordination of strategic activities with Global Subject Matter Experts (SMEs), Local Regulatory Bodies and Industry Associations. Secure flow of information from/to authorities, industry associations and the company's Life Science business. And closely work with global/regional regulatory surveillance &advocacy team and regulatory SMEs to link the local advocacy activities with global/regional advocacy activities.

**Who You Are**:

- Bachelor's degree from Faculty of Pharmacy is a must (Being registered with the South African Pharmacy Council will be an asset.)
- Knowledgeable of EU and local country scheduled substances, ABPs, IVD-Medical Device, import/export regulations of controlled chemicals
- Minimum of 3 years of relevant industry experience in Regulatory and/or Trade Compliance area within a Life Science Company.
- Proficient in MS Office Software (Word, Excel, PowerPoint, Project) and ERP Systems.(Good Knowledge on SAP PRE will be an asset)
- Demonstrate good communication & project management skills. Strong planning, follow up, reporting and analytical skills to achieve accurate and timely results,
- Ability to work effectively in multi-cultural teams and openness to travel

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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