Director Global Regualtory Affairs

Fresenius Medical Care • Waltham, MA

249d

About The Position

Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays a critical role in influencing regulatory decisions, managing complex global submissions, and ensuring successful product development, approval, and market access for FME's product portfolio. The Global Strategy Leader will work closely with internal and external stakeholders to align regulatory strategies with business objectives and drive the timely delivery of high-quality pharmaceutical products.

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.

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.

Benefits

• 10 - 15% domestic and international travel required.

What This Job Offers

• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees