Director - Global Regulatory Affairs

September 5

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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

• Develop and execute global regulatory strategies for radiopharmaceutical diagnostics products. • Collaborate with cross-functional teams and manage regulatory submissions. • Ensure compliance with international regulatory requirements.

Requirements

• Bachelor’s degree required; Advanced degree in life sciences, pharmacy, chemistry, or a related field preferred. • 10+ years of experience in regulatory affairs, with a strong focus on regulatory strategy for global drug development. • Proven track record of successful global regulatory submissions and approvals. • In-depth knowledge of global regulatory requirements and guidelines for both small molecule and biologics drug development. • Experience in radiopharmaceuticals and/or diagnostics drug products preferred. • Experience in leading and managing regulatory teams. • Strong analytical, strategic thinking, and problem-solving skills. • Excellent communication and negotiation skills. • Ability to work effectively in a fast-paced, dynamic environment with changing priorities. • Experience in regulatory interactions with global health authorities, including FDA and EMA. • Proven ability to manage multiple projects and priorities simultaneously.

Benefits

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