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Regulatory Affairs Specialist

Posted about 23 hours agoViewed

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💎 Seniority level: Senior, 5+ years

📍 Location: USA, Eastern and Central states

🔍 Industry: Medical and Healthcare

🏢 Company: Innovativ Pharma, Inc.

⏳ Experience: 5+ years

🪄 Skills: Project ManagementAgileArtificial IntelligenceData AnalysisGCPCross-functional Team LeadershipProduct DevelopmentCommunication SkillsAnalytical SkillsProblem SolvingNegotiationDocumentationComplianceTrainingQuality AssuranceRisk Management

Requirements:
  • A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.
  • A minimum of 5 years of experience in an FDA or highly regulated industry required.
  • A minimum of 2-3 years in a Regulatory Affairs role required.
  • Experience with software as a medical device, Agile development, and/or artificial intelligence preferred.
Responsibilities:
  • Possesses and applies knowledge, skills/abilities, and understanding of the regulatory and legal frameworks, regulatory requirements, and processes and procedures focused in the areas of our medical and healthcare portfolio.
  • Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
  • Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
  • Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
  • Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
  • Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.
  • Negotiates with regulatory authorities throughout the product lifecycle.
  • Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
  • Assists other departments in the development of SOPs to ensure regulatory compliance.
  • Provides regulatory input and technical guidance on global regulatory requirements to product development teams..
  • Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.
  • Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
  • Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
  • Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process.
  • Provides regulatory information and guidance for proposed product claims/labeling.
  • Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
  • Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
  • Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.
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