Director Global Regualtory Affairs

Director Global Regualtory Affairs

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field (Advanced degree such as a Master’s, PhD, or MBA is highly preferred)
• Regulatory Affairs Certification (e.g., RAC) is preferred
• 12+ years of experience in regulatory affairs, focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry
• Proven experience in leading global regulatory strategy for complex pharmaceutical products across multiple regions (FDA, EMA, HC, etc.)
• Strong expertise in navigating regulatory pathways for drug strategy, from preclinical through post-market
• Demonstrated success in leading and mentoring a team of regulatory professionals in a fast-paced, global environment
• Experience managing large-scale global regulatory submissions, including IND/CTAs, NDAs, NDSs, and MAAs, etc.
• Strategic thinker with a deep understanding of the global regulatory environment and pharmaceutical industry trends
• Exceptional leadership and team-building skills, with the ability to manage and inspire cross-functional teams
• Strong project management skills, with a proven track record of delivering regulatory submissions on time and within scope
• Excellent communication, presentation, and negotiation skills, with the ability to influence senior leadership and regulatory agencies
• Analytical mindset, capable of identifying risks and proposing solutions to address regulatory challenges
• Proven ability to navigate complex regulatory landscapes and deliver strategic solutions that drive product success

Responsibilities

• Lead the development of global regulatory strategies for the company’s pharmaceutical portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions
• Collaborate with senior leadership in medical/clinical development, commercial, and other functional areas to align regulatory strategy with overall product development and business objectives
• Provide expert guidance on regulatory requirements, market access strategies, and potential risks to inform decision-making across the organization
• Oversee the planning, preparation, and execution of global regulatory submissions to ensure timely approval and market access across key regions (e.g., FDA, EMA, Health Canada, etc.)
• Ensure the integration of regulatory considerations into all stages of product development, including preclinical, clinical/medical, CMC, and post-market phases
• Monitor regulatory trends, updates, and guidance from global agencies, ensuring the company’s strategies remain aligned with changing regulatory requirements
• Serve as a regulatory contact for cross-functional teams, ensuring alignment on regulatory strategy and execution across global markets
• Work closely with commercial, clinical/medical, and manufacturing teams to ensure timely and successful regulatory approval of products, addressing any regulatory challenges that arise
• Lead interactions with regulatory agencies and stakeholders worldwide to advocate for regulatory positions, influence decisions, and expedite approvals
• Identify and manage regulatory risks associated with the global development and commercialization of pharmaceutical products
• Ensure compliance with local and global regulatory standards, including FDA, EMA, ICH, and other regulatory bodies, to maintain market access and product integrity
• Develop and implement strategies to address potential regulatory roadblocks or challenges, ensuring the company remains on track to meet business goals
• Lead, mentor, and develop a high-performing team of regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement
• Build and maintain strong, productive relationships with global regulatory authorities and external stakeholders, such as consultants, regulatory agencies, and industry groups
• Provide leadership in managing global regulatory submissions, ensuring efficient and high-quality execution
• Assess and anticipate the competitive landscape and market trends to inform the regulatory strategy and market access plans
• Utilize market intelligence and regulatory data to optimize product lifecycle management, regulatory strategy, and portfolio prioritization

Preferred Qualifications

• Advanced degree such as a Master’s, PhD, or MBA is highly preferred
• Regulatory Affairs Certification (e.g., RAC) is preferred