Director, Technical Regulatory (CMC and Emerging Technologies)

August 21

🏡 Remote – New York

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Logo of Telxius

Telxius

Enabling communication with our 80.000 km high-capacity fiber optic submarine cables, our Tier 1 IP backbone #AS12956

Towers and Cable

201 - 500

💰 Venture Round on 2017-09

Description

• Responsible for leading and managing all CMC and regulatory activities for pharmaceutical products • Ensure all global regulatory submissions have high-quality CMC dossiers • Lead the development of the company’s regulatory strategy for emerging technologies

Requirements

• Bachelor’s degree required; Advanced degree (Ph.D., Pharm.D., or equivalent) preferred • 10+ years of experience in Regulatory Affairs, with a focus on CMC • Proven leadership and management experience • In-depth knowledge of global regulatory requirements and guidelines • Excellent verbal and written communication skills • Strong project management skills • Strong analytical and problem-solving skills • Strong interpersonal skills

Benefits

• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development

Apply Now
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