Assistant Manager- Regulatory

3 weeks ago

Gurgaon, Haryana, India Johnson & Johnson Full time
The Associate Regulatory Affairs Manager has the responsibility to Support regulatory department to ensure efficient and compliant business processes and environment. Assists in the registration of new products/changes/renewal licenses by preparing documentation needed for registration submissions in India, Sri Lanka and Bangladesh. The Associate Regulatory Affairs Manager will independently, with minimum supervision, initiate and prepare the regulatory submissions, interact with Business Units Regulatory affairs teams, interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on India, Sri Lanka and Bangladesh as needed and be able to interact and work as a strategic partner with cross functional team members on regulatory solutions. Combines knowledge of scientific, regulatory and business issues to enable JJV products to meet required legislation. Has department/site level influence and is generally recognized as an expert resource within the department. Identifies emerging regulatory issues and analyses broad scope implications of changing regulations and guidance. Identifies data needed, obtains these data and ensures that they are effectively presented for the registration of products in the region. Utilizes technical regulatory skills to propose strategies on complex issues.
Adheres to environmental policy, procedures, and supports department environmental objectives.
  • Determine and communicate submission and approval requirements.
  • Participate in new product development teams to provide input and expertise on regulatory requirements, determination of global regulatory strategies, review and approval of documentation to support regulatory submissions worldwide.
  • Assess the acceptability of documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval.
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies and complete all regulatory projects as assigned
  • Proactive in providing strategies/creative ideas for improvements and fast regulatory processes
    • Prepare labelling and ensure all labelling activities are accordance to the internal SOP.
    • Participate in all intercompany audits
    • Participate in all monthly & quarterly meetings/review
    • 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 labelling, 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.
    • Able to manage the team of 3-4 individuals

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