GLOBAL REGULATORY SPECIALIST SKILLS, EXPERIENCES, AND JOB REQUIREMENTS
Published: Apr 21, 2025 - The Global Regulatory Specialist demonstrates strong communication, analytical, and negotiation skills to engage effectively with internal teams and international Health Authorities. This role requires expertise in regulatory submissions, clinical trial support, and lifecycle management while ensuring compliance with global and domestic regulations. The specialist applies a detail-oriented mindset and risk management knowledge to drive continuous improvement and maintain regulatory excellence.
Essential Hard and Soft Skills for a Global Regulatory Specialist Resume
- Regulatory Documentation
- Data Analysis
- Regulatory Compliance
- System Proficiency
- Information Gathering
- Product Release
- Data Collection
- System Analysis
- Quality Review
- Document Oversight
- Cross-Functional Collaboration
- Change Management
- Stakeholder Engagement
- Process Alignment
- Project Management
- Team Mentoring
- Partner Liaison
- Product Stewardship
- Respectful Communication
- Relationship Management
Summary of Global Regulatory Specialist Knowledge and Qualifications on Resume
1. BA in Regulatory Affairs with 5 years of Experience
- Fluent in English (spoken and written) and having some skills in a further language
- Competent user of MS Windows and standard office software tools (Word, Excel, PowerPoint)
- Working experience in Product Registration
- Ability to work within and contribute to cross-functional teams
- Clear evidence of results orientation and project coordination/management skills
- Familiarity with product registration requirements and regulatory science issues
- Experience in influencing others to accomplish objectives
- Experience in working well in teams that often include cross-functional and external participants from various cultures and time zones
- Experience in continuous improvement and learning
- Experience in adapting to changing demands
- In-depth knowledge in a particular registration, product safety or Regulatory chemistry discipline such as toxicology, ecotoxicology or environmental fate
- Well-developed communication and presentation skills
- Must have close attention to detail and are comfortable reviewing and documenting technical information
2. BA in Clinical Research with 2 years of Experience
- Fundamental understanding of the importance of following the approved process
- Proven project management and multi-tasking skills
- Strong communication and interpersonal skills
- Ability to work with people of other cultures
- Strong planning and organization skills
- Strong attention to detail and proven mastery of MS Word and MS Excel
- Experience in working under tight deadlines
- Proven experience in the financial services industry, in regulatory, legal and compliance or risk environment
- Proven ability to independently prioritize work to meet or exceed timelines
- Proficiency in written and spoken English
- Experience in project management
3. BA in Environmental Health with 4 years of Experience
- Outstanding communication and presentation skills with the ability and confidence to discuss issues at a senior level
- Good attention to detail and proven ability to tackle issues in an effective and collaborative manner
- Ability to positively question the status quo and strive for improvements
- Hardworking self-starter motivated for professional and personal development
- Proven ability to manage work well under pressure
- Experience engaging and global Health Authorities (EMA, MHRA, BfArM and/or HPRA)
- Experience with prescription drug registration submissions and lifecycle management, including clinical trial activities
- Strong computer skills with the ability to learn to use multiple databases
- Up-to-date knowledge and experience of regulated domestic and international environments for therapeutic goods
- Ability to negotiate with internal and external functions, including Health Authorities
- Solid understanding of risk management processes
- Experience in the pharmaceutical industry, prescription medicines, experimental drugs or products supplied via access schemes