Regulatory Affairs Specialist
Regulatory Affairs Specialist
Augment Jobs
Los Angeles, CA
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Job Description: Regulatory Affairs Specialist
Position Overview: We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements, preparing regulatory submissions, and supporting regulatory inspections and audits. This role requires a strong understanding of regulatory standards, excellent organizational skills, and the ability to collaborate effectively with cross-functional teams.
Roles And Responsibilities
Position Overview: We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements, preparing regulatory submissions, and supporting regulatory inspections and audits. This role requires a strong understanding of regulatory standards, excellent organizational skills, and the ability to collaborate effectively with cross-functional teams.
Roles And Responsibilities
- Regulatory Compliance:
- Interpret and monitor applicable laws, regulations, and guidelines relevant to the organization’s products, processes, and operations.
- Ensure compliance with regulatory requirements including FDA, EMA, ISO, and other relevant regulatory bodies.
- Maintain up-to-date knowledge of regulatory changes and developments impacting the industry.
- Regulatory Submissions:
- Prepare and submit regulatory documents, filings, and applications to regulatory authorities for product approvals, registrations, and certifications.
- Coordinate the preparation of technical documentation, labeling, and packaging requirements in accordance with regulatory standards.
- Quality Assurance and Control:
- Support quality assurance activities including document control, change management, and product lifecycle management.
- Conduct internal audits and assessments to verify compliance with regulatory requirements and quality standards.
- Implement corrective and preventive actions (CAPAs) based on audit findings and regulatory inspections.
- Cross-functional Collaboration:
- Collaborate with R&D, manufacturing, marketing, and legal teams to ensure regulatory compliance throughout product development and commercialization processes.
- Provide regulatory guidance and support to cross-functional teams to facilitate timely product launches and market approvals.
- Regulatory Inspections and Audits:
- Prepare for and participate in regulatory inspections, audits, and meetings with regulatory authorities.
- Coordinate responses to inspection findings and ensure timely resolution of compliance issues.
- Documentation and Reporting:
- Maintain regulatory documentation, records, and regulatory files in compliance with documentation standards.
- Prepare and submit regulatory reports, status updates, and compliance metrics to management and regulatory authorities as required.
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Pharmacy, Chemistry, or a related field. Advanced degree or regulatory certifications (e.g., RAC) preferred.
- 3-5 years of experience in regulatory affairs within the pharmaceutical, medical device, biotechnology, or healthcare industry.
- Strong knowledge of regulatory requirements, standards, and guidelines (e.g., FDA, EMA, ISO).
- Experience preparing and submitting regulatory filings, submissions, and documentation.
- Excellent analytical and problem-solving skills, with attention to detail and accuracy.
- Effective communication and interpersonal skills, with the ability to collaborate across functional areas and influence stakeholders.
- Ability to prioritize tasks, manage multiple projects, and meet deadlines in a fast-paced environment.
- Proficiency in regulatory affairs software, document management systems, and Microsoft Office Suite (Word, Excel, PowerPoint).
- Competitive salary based on experience and qualifications.
- Performance-based bonuses, comprehensive benefits package including health insurance and retirement plans.
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Seniority level
Associate -
Employment type
Full-time -
Job function
Legal -
Industries
Financial Services
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