Coordinator Regulatory Affairs (m/f/d) – Central America & Caribbean

• Work & Life: Flexible working hours and the option for mobile working.

• Connect & Grow: Numerous company celebrations such as the Oktoberfest visit, summer party, carnival, and Christmas party, an annual team event, and regular after-work events on our roof terrace.

• Share & Create: Open exchange and feedback, e.g., through monthly pulse surveys to capture everyone's mood and derive changes, as well as regular feedback and development talks with your manager.

• Level up: Focus on and development of your strengths and how you can use them for yourself and your work, as well as need-based internal and external workshops for your personal and professional growth.

• Access to healing: Health and fitness cooperation with EGYM Wellpass – offering various sports facilities (e.g., gyms, yoga studios, swimming pools, massages) across Germany, plus free food supplements and snacks (fruit, nuts & ice cream).

• Buddy Program: A go-to person for all kinds of questions and support with networking, plus a "Get Together Lunch".

• You can also look forward to: A €150 shopping card, exclusive corporate benefits discounts, a performance-based bonus, additional premiums for reaching sales targets, a company pension scheme, and much more!

Regulatory Management

• Dossier Preparation: Actively participate in the revision of pharmaceutical-technical dossiers (EU-CTD and country-specific formats) to precisely meet the regulatory requirements in Central America and the Caribbean

• Submission Planning: Support the timely submission of first submissions and renewals to ensure continuous market availability of our products in the region

• Certificate Management: Keep an eye on the status of marketing authorizations and work with the team to develop measures that ensure reliable compliance with the submission plan for our target markets

Partner Management

• Network Building: Maintain relationships with contract manufacturers, internal and external customers, and our local partners on site. By doing so, you contribute to a resilient network and our successful presence in Central America and the Caribbean

• Partner Communication: Coordinate communication with our regulatory partners in the region and evaluate their performance to continuously optimize our collaboration

Process Optimization

• Documentation: Assist in the creation and maintenance of country-specific checklists and process documentation to guarantee the highest quality and compliance standards

• Optimization: Proactively bring in your ideas for process improvement and implement targeted measures to make our regional workflows even more efficient

Capacity Planning

• Budget Planning: Support the team with capacity and budget planning for Central America and the Caribbean, creating a solid foundation for our strategic decisions

• Education: You have a completed degree in Pharmacy, Natural Sciences, or a comparable field – this base forms the foundation for your regulatory work

• Practical Experience: You have already gained initial practical experience in Regulatory Affairs or a highly regulated environment, for instance through internships, working student positions, or a first role in the pharmaceutical industry

• Expertise: You navigate confidently in the areas of Quality Assurance, Pharmaceutical Technology, and Pharmacovigilance, and bring solid foundational knowledge of pharmaceutical texts and dossier formats

• Language Skills: Good Spanish and German skills (both at least B2 level) in spoken and written form are a matter of course for you. Additional English skills are a clear nice-to-have for us

• Work Style: A structured, timely, and cost-efficient way of working characterizes you, and you know how to set priorities and confidently manage multiple projects simultaneously

• Communication Skills: Ideally, you bring a confident demeanor when collaborating with local partners and authorities and can communicate complex regulatory matters clearly and comprehensibly

• AI Mindset: You are open to trying out AI-supported tools – for example, for structured research of regulatory requirements in Central America and the Caribbean, the preparation of dossier content, or the quality check of translations – thus contributing to making our regulatory processes smarter and more efficient

• Work & Life: Flexible working hours and the option for mobile working

• Connect & Grow: Numerous company celebrations such as the Oktoberfest visit, summer party, carnival, and Christmas party, an annual team event, and regular after-work events on our roof terrace

• Share & Create: Open exchange and feedback, e.g., through monthly pulse surveys to capture everyone's mood and derive changes, as well as regular feedback and development talks with your manager

• Level up: Focus on and development of your strengths and how you can use them for yourself and your work, as well as need-based internal and external workshops for your personal and professional growth

• Access to healing: Health and fitness cooperation with EGYM Wellpass – offering various sports facilities (e.g., gyms, yoga studios, swimming pools, massages) across Germany, plus free food supplements and snacks (fruit, nuts & ice cream)

• Buddy Program: A go-to person for all kinds of questions and support with networking, plus a "Get Together Lunch"

• You can also look forward to: A €150 shopping card, exclusive corporate benefits discounts, a performance-based bonus, additional premiums for reaching sales targets, a company pension scheme, and much more!