Scientific & Regulatory Affairs Manager

Overview

Job Description

Duties & Responsibilities

• Ensures compliance with regulatory requirements and standards in the industry.
• Developing and implementing regulatory strategies, collaborating with cross-functional teams, and ensuring that products and processes meet all relevant regulatory guidelines.
• Develop new tools, standards, and approaches to assess the safety, efficacy, quality and performance of all products.
• Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
• Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Legal to ensure that all regulatory requirements are met throughout the product lifecycle.
• Prepare and submit regulatory submissions, including but not limited to product registrations, pre-market notifications, and post-market surveillance reports.
• Liaise with regulatory authorities and act as the primary point of contact during inspections, audits, and regulatory agency interactions.
• Conduct risk assessments and develop mitigation strategies to manage regulatory risks.
• Review and approve product labeling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.
• Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory requirements are incorporated into the development process.
• Monitor and track regulatory compliance metrics and provide regular reports to senior management.
• Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.

Skills & Competencies

Educational / Work Experiences

Job Types : Full-time, Permanent

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