Junior Regulatory Affairs Manager GSA

"Are you a detail-oriented and motivated individual with a passion for the pharmaceutical industry? Sanofi, a leading global healthcare company, is seeking a Junior Regulatory Affairs Manager to join our team in the GSA (Germany, Switzerland, Austria) region. As a key player in the development and commercialization of our products, you will play a crucial role in ensuring compliance with regulatory requirements. If you have a strong understanding of regulatory affairs and are driven to make a meaningful impact, we invite you to apply for this exciting opportunity."

1. Ensure compliance with all regulatory requirements in the GSA region, including laws, regulations, and guidelines related to pharmaceutical products.
2. Develop and maintain a thorough understanding of the regulatory landscape in the GSA region, including changes and updates to regulations.
3. Collaborate with cross-functional teams to ensure that all products and processes are in alignment with regulatory requirements.
4. Assist in the preparation and submission of regulatory documents, including drug applications, labeling, and other required reports.
5. Monitor and track the progress of regulatory submissions and ensure timely completion.
6. Review and analyze scientific and technical data to support regulatory submissions and ensure accuracy and completeness.
7. Keep up-to-date with industry trends and best practices in regulatory affairs, and apply this knowledge to improve processes and procedures.
8. Work closely with internal and external stakeholders, including regulatory agencies, to address any issues or questions related to regulatory compliance.
9. Participate in regulatory inspections and audits, and assist with the implementation of corrective and preventive actions.
10. Maintain accurate and organized records of all regulatory documentation and submissions.
11. Contribute to the development and implementation of regulatory strategies for new and existing products.
12. Train and mentor junior regulatory affairs team members, providing guidance and support as needed.
13. Communicate effectively with all levels of the organization, providing updates and reports on regulatory activities and issues.
14. Proactively identify and address potential regulatory risks and issues, and develop solutions to mitigate them.
15. Represent the company in external meetings and conferences related to regulatory affairs.

According to JobzMall, the average salary range for a Junior Regulatory Affairs Manager GSA in Berlin, Germany is €50,000 to €70,000 per year. This can vary depending on the specific company, industry, and level of experience.

Sanofi SA is a French multinational pharmaceutical company headquartered in Paris, France, the world's fifth-largest by prescription sales. Building a More Equitable Future through Inclusive Clinical Trials · Rethinking the science of COPD · Grassroots Manufacturing Solutions for a Healthier Planet.