Associate Director, Global Regulatory Affairs

Job Description

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The Associate Director, Global Regulatory Affairs is a key member of the Global Regulatory Affairs team, responsible for providing strategic regulatory guidance, support, and expertise to the organization. This role will collaborate closely with cross-functional teams, including R&D, Manufacturing, Quality, and Commercial, to ensure compliance with global regulations and industry standards.

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Key Responsibilities

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• Develop and maintain a deep understanding of global regulations, industry standards, and best practices, including but not limited to, FDA, EMA, ICH, and WHO guidelines.
• Provide strategic regulatory guidance and support to project teams to ensure compliance with global regulations and industry standards.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Quality, and Commercial, to develop and implement regulatory strategies that meet business objectives.
• Develop and maintain effective working relationships with global regulatory authorities, including FDA, EMA, and other regional regulatory agencies.
• Represent the organization in industry associations and working groups, contributing to the development of global regulatory policies and guidelines.
• Manage and coordinate the preparation of regulatory submissions, including NDAs, BLAs, and other filings, to ensure timely and successful approval.
• Develop and maintain regulatory intelligence, including tracking and analyzing global regulatory trends, policy changes, and industry best practices.
• Identify and communicate regulatory risks and opportunities to senior management and other stakeholders.
• Develop and implement process improvements to increase efficiency, quality, and compliance in regulatory affairs.
• Manage and mentor junior staff, providing guidance, training, and support to ensure their success.

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Requirements

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• Advanced degree in a life science or related field (e.g., Ph.D., MS, or BS).
• At least 8 years of experience in global regulatory affairs, with a focus on pharmaceuticals, biologics, or medical devices.
• Proven track record of success in developing and implementing regulatory strategies, managing regulatory submissions, and interacting with global regulatory authorities.
• Excellent communication, project management, and leadership skills.
• Ability to work in a fast-paced, dynamic environment, with multiple priorities and deadlines.
• Fluency in English, with excellent written and verbal communication skills.

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What We Offer

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• A competitive salary and benefits package.
• Opportunities for career growth and professional development.
• A dynamic, collaborative, and supportive work environment.
• Flexible work arrangements, including remote work options.

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Contact Information

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If you're interested in this exciting opportunity, please submit your application, including your resume and cover letter, to careers@example.com.