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Regulatory Affairs Manager

2 months ago

Thousand Oaks, California, United States Innova Solutions Full time

Job Summary:

Innova Solutions is seeking a highly skilled Regulatory Affairs Manager to facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout the product lifecycle.

Key Responsibilities:

  • Develop and execute regulatory strategies to ensure compliance with global regulatory requirements.
  • Collaborate with cross-functional teams to ensure regulatory requirements are integrated into product development and manufacturing processes.
  • Manage and maintain product regulatory history documents and ensure compliance with submissions to regulatory agencies.
  • Coordinate with regional regulatory representatives to support regional regulatory activities, including IMPD development and submission, and advisory committee meeting preparations.
  • Ensure quality control of regulatory documentation, including briefing packages.

Requirements:

  • Proven experience in regulatory affairs, with a focus on product development and global registration.
  • Strong knowledge of regulatory requirements and guidelines, including those related to product manufacturing and quality programs.
  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
  • Ability to analyze complex regulatory information and develop effective strategies to ensure compliance.

About Innova Solutions:

Innova Solutions is a global technology and business transformation solutions provider, with a strong reputation for delivering high-quality services to our clients. We are committed to providing our employees with a challenging and rewarding work environment, and we offer a range of benefits and opportunities for professional growth and development.