Scientific & Regulatory Affairs Manager

Overview

Job Description

• Maintains compliance with regulatory requirements and standards in the industry.
• Develops and implements regulatory strategies, collaborates with cross-functional teams, and ensures products and processes meet relevant regulatory guidelines.
• Develops new tools, standards, and approaches to assess the safety, efficacy, quality and performance of all products.
• Develops and executes regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
• Stays updated on changes in regulatory requirements and translates them into actionable steps for the organization.
• Collaborates with cross-functional teams including R&D, Quality Assurance, and Legal to ensure that all regulatory requirements are met throughout the product lifecycle.
• Prepares and submits regulatory submissions, including product registrations, pre-market notifications, and post-market surveillance reports.
• Liaises with regulatory authorities and acts as the primary point of contact during inspections, audits, and regulatory agency interactions.
• Conducts risk assessments and develops mitigation strategies to manage regulatory risks.
• Reviews and approves product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.
• Provides regulatory guidance and support to internal stakeholders, including product development teams, to ensure regulatory requirements are incorporated into the development process.
• Monitors and tracks regulatory compliance metrics and provides regular reports to senior management.
• Maintains a thorough understanding of international regulations in relevant markets and guides the organization regarding international expansion plans.

Skills & Competencies

Educational / Work Experiences

Seniority level

Employment type

Job function

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