Director, Global Regulatory Affairs Operations (RegOps)

March 27

Telxius

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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

• Play a pivotal role in ensuring regulatory compliance and operational efficiency across international markets • Lead team responsible for coordinating regulatory submissions, managing regulatory documentation, and driving strategic initiatives to streamline regulatory processes

Requirements

• Bachelor's degree in life sciences, pharmacy, or related field required; advanced degree preferred • 8+ years of experience in regulatory affairs operations within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership role • Expert knowledge of technical requirements for electronic submissions and data standards • Prior experience with a RIM system required; RIM system implementation strongly preferred • Proven track record of successful regulatory submissions and approvals in multiple regions (e.g., FDA, EMA, Health Canada, PMDA) • Strong understanding of global regulatory requirements and guidelines governing drug development and registration • Excellent leadership, communication, and interpersonal skills • Ability to effectively manage multiple priorities in a fast-paced environment • Experience with regulatory document management systems and electronic submission platforms is desirable • Ability to travel globally up to 10%

Benefits

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