Vice President of Regulatory Affairs - Remote

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.