Regulatory Affairs Consultant - Global Asset Lead (home or office based in various European locations)
Bucharest, Romania Additional Locations Czech Republic-Prague; Czech Republic-Remote; Hungary-Budapest; Hungary-Remote; Poland-Remote; Poland-Warsaw-Business Garden; Romania-Remote; Serbia-Belgrade; Serbia-Remote Job ID R0000032008 Category Consulting Date Posted 04/25/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Parexel are seeking a highly skilled International Markets Regulatory Affairs Expert to join our dynamic team! We are looking for an experienced Regulatory Affairs professional with a broad understanding of regulatory science and requirements across international regions, particularly in emerging markets. The successful candidate will provide strategic guidance on regulatory submissions and lifecycle maintenance across international regions. If you are passionate about regulatory affairs and want to make a significant impact in the pharmaceutical industry, we encourage you to apply.
This role can be home or office based is selected European locations.
Key Responsibilities:
Develop International Regulatory Submission Strategies for a wide variety of products/projects
Support Project Leads in optimizing strategies for specific submissions in local markets
Guide delivery teams in creating International dossiers
Identify and mitigate risks related to international submissions
Conduct regulatory intelligence surveys and provide objective assessments
Represent the company at health authority meetings and document discussions and agreements
Coach, mentor, and lead regulatory teams to ensure timely and quality delivery of objectives
Monitor and advise on key changes in the regulatory environment of International markets
Qualifications:
University Degree in a Scientific or Technical Discipline
Several years of experience in pharmaceutical regulatory affairs, particularly in international markets
Broad background in pharmaceutical business and experience in various regulatory affairs areas (e.g., Global, European, International, Marketing Company, or health authority experience)
Strong project management skills
Excellent interpersonal and intercultural communication skills
Proficiency in local language and extensive working knowledge of English
Critical thinking and problem-solving skills
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