Remote Director, Global Regulatory Affairs – Precision Medicine

Summary

Join Telix Pharmaceuticals, a dynamic and fast-growing radiopharmaceutical company, as the Director of Global Regulatory Affairs. This senior leadership position involves developing and executing global regulatory strategies for drug products, collaborating with cross-functional teams, managing regulatory submissions, and ensuring compliance with international regulatory requirements.

Requirements

• Bachelor’s degree required; Advanced degree in life sciences, pharmacy, chemistry, or a related field (Ph.D., Pharm.D., or M.S.) 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, with a demonstrated ability to mentor and develop staff
• Strong analytical, strategic thinking, and problem-solving skills
• Excellent communication and negotiation skills, with the ability to influence and build consensus across diverse teams
• 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

Responsibilities

• Lead the development and implementation of global regulatory strategies for small molecule products, from early development through commercialization
• Identify and mitigate regulatory risks, ensuring alignment with business objectives and timelines
• Provide strategic regulatory guidance to cross-functional teams, including R&D, clinical, manufacturing, and commercial teams
• Oversee the preparation, submission, and management of regulatory filings, including INDs, NDAs, BLAs, MAAs, and other global regulatory submissions
• Liaise with global health authorities, including the FDA, EMA, and other regulatory bodies, to facilitate product approvals
• Ensure timely responses to regulatory inquiries and oversee the negotiation of regulatory pathways
• Ensure that all regulatory activities are conducted in compliance with applicable laws, regulations, and guidelines
• Monitor the global regulatory environment, assess the impact of new regulations, and communicate changes to relevant stakeholders
• Develop and implement regulatory policies, procedures, and best practices
• Lead, mentor, and develop a high-performing global regulatory affairs team
• Foster a collaborative and innovative team culture, promoting professional growth and continuous learning
• Allocate resources effectively to meet project timelines and regulatory goals
• Collaborate with internal and external stakeholders, including clinical, manufacturing, legal, and commercial teams, to ensure regulatory alignment
• Represent regulatory affairs in senior management meetings and decision-making processes
• Build and maintain relationships with key regulatory agencies and external partners
• Provide regulatory due diligence and support for business development activities, including mergers and acquisitions, licensing, and partnership opportunities
• Assess regulatory risks and opportunities for potential new projects or acquisitions

Benefits

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