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Skills
- On-time license renewal
- Audit preparation and response
- Knowledge of clinical research regulations
- Excellent attention to detail
- Stakeholder relationship management
- Data-driven decision making
- Knowledge of ISO standards
- Regulatory Intelligence Gathering
- Project management in regulatory environments
- Leadership in compliance-driven teams
Work Experiences
- Achieved accelerated approvals for [Number] consecutive years.
- Achieved [Award] recognition for compliance excellence.
- Achieved timely approval of [Number] new products.
- Reviewed and disseminated regulatory updates weekly, ensuring the company maintained compliance with evolving global regulations.
- Oversaw post-market surveillance activities in accordance with [Regulation Name], leading to a [Percentage]% reduction in regulatory review findings.
- Formulated strategies to address regulatory gaps in submissions, leading to a reduction in approval delays by [Number] months.
- Reduced approval timelines by [Number] months.
- Streamlined global submission processes.
- Successfully defended product labeling during a regulatory audit.
- Resolved compliance issues with [Product Type].
Summaries
- Ensured no compliance delays for [Product Type].
- Avoided compliance issues.
- Thorough understanding of [Regulation Name] regulatory standards.
- Dedicated to reducing non-compliance risks by aligning preclinical and regulatory strategies, ensuring development pipelines remained clear of delays.
- Highly proficient in organizing and executing regulatory document submissions to achieve seamless approvals, ensuring no compliance delays for [Product Type].
- Thorough in reviewing promotional materials for compliance with [Regulation Name] standards, resulting in zero findings during external regulatory audits, boosting product credibility.
- Complied with regulatory guidelines.
- Spearheaded the completion of regulatory dossiers.
- Successfully managed complex submission timelines.
- Conducted post-market surveillance.
Accomplishments
- Authored comprehensive regulatory submissions for [Product Type], ensuring adherence to the latest ICH and regional guidelines.
- Provided regulatory support for cross-functional teams during product development, contributing to a [Percentage]% increase in project approval success.
- Enhanced coordination between clinical affairs and regulatory teams to expedite approval timelines for amendments by [Number] months.
- Managed multiple regulatory inspections and pre-approval inspections (PAIs), ensuring compliance with all applicable regulatory standards.
- Streamlined clinical trial protocol reviews, ensuring compliance with FDA and EMA regulations while reducing review times by [Number]%.
- Supported multiple product submissions by conducting gap analysis, leading to an on-time approval rate of [Percentage]% for new medical devices.
- Collaborated with quality assurance teams to establish SOPs that streamlined post-market surveillance and ensured regulatory compliance.
- Improved labeling review processes for [Product Type], reducing errors and adhering to compliance by [Percentage]%.
- Provided regulatory impact assessments for [Number+] cross-functional projects, allowing the business to mitigate risks effectively.
- Developed risk mitigation strategies that mitigated compliance-related setbacks by [Percentage]%, solidifying the company’s market reputation.
Affiliations
- American Chemical Society (ACS) Regulatory Science Interest Group
- International Conference on Harmonisation (ICH)
- Member of the Global Organization for Regulatory Affairs (GORA)
- American Pharmacists Association (APhA)
- Association of Clinical Research Professionals (ACRP)
- Society for Clinical Research Sites (SCRS)
- European Medicines Agency (EMA) Working Groups
- Association of International Pharmaceutical Manufacturers (AIPM)
- Global Regulatory Sciences Groups [Region/Technology] Working Groups
- Active Mentor in Regulatory Science Development Program [Program Name]
Certifications
- Certified Clinical Project Manager (CPM), [Year]
- Risk Management Certification (RMP), [Year]
- SQF (Safe Quality Food) Practitioner Certification, [Year]
- Certified Regulatory Compliance Professional (CRCP), [Year]
- Certified Quality Engineer (CQE) - [ASQ], [Year]
- ISO 9001:2015 Internal Auditor Certification – [Year]
- Postgraduate Diploma in Medical Device Regulatory Affairs, [University/Institution], [Year]
- Certificate in International Regulatory Affairs, [Professional Body/University], [Year]
- Certificate in Drug Development and Regulatory Affairs, [University/Organization], [Year]
- Postgraduate Diploma in Pharmacovigilance, [University/Institution], [Year]
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