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Vice President of Regulatory Affairs - Remote

Posted 35 weeks ago

Overview

Luminary Group is seeking a highly skilled and experienced Vice President of Regulatory Affairs to join our client. As the Vice President of Regulatory Affairs, you will play a critical role in the development and implementation of regulatory strategies to support our client's products in the pharmaceutical, biotechnology, and medical device industries.

In Short

  • Lead the regulatory affairs function and provide strategic guidance to ensure compliance with global regulatory requirements.
  • Develop and execute regulatory strategies for product development, registration, and post-approval activities.
  • Interact with regulatory authorities and participate in meetings and negotiations.
  • Monitor and interpret changing regulatory trends and requirements.
  • Collaborate with cross-functional teams to review and prepare regulatory submissions.
  • Oversee the preparation of regulatory documents.
  • Ensure compliance with regulatory reporting requirements and timelines.
  • Manage and mentor a team of regulatory professionals.
  • Stay up-to-date with global regulatory guidelines and requirements.
  • Collaborate with internal stakeholders for regulatory guidance.

Requirements

  • Extensive experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industries.
  • Strong knowledge of global regulatory requirements and submission processes.
  • Proven leadership and team management skills.
  • Excellent communication and negotiation skills.
  • Ability to interpret complex regulatory guidelines.
  • Experience in preparing INDs, NDAs, and BLAs.
  • Strong analytical and problem-solving abilities.
  • Ability to work collaboratively in a cross-functional environment.
  • Detail-oriented with strong organizational skills.
  • Advanced degree in a relevant field is preferred.

Benefits

  • Competitive salary and performance-based bonuses.
  • Comprehensive health and wellness benefits.
  • Opportunities for professional development and training.
  • Flexible work arrangements, including remote work options.
  • Supportive and collaborative work environment.
  • Access to cutting-edge industry resources and tools.
  • Potential for career advancement within the organization.
  • Engagement in meaningful work that impacts public health.
  • Networking opportunities within the industry.
  • Work-life balance initiatives.

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