Director Global Regulatory Affairs

This position is a remote, within the United States.

PURPOSE AND SCOPE:

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.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Regulatory Strategy Leadership:
  • 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.

• Global Regulatory Submissions:
  • 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.). Including global chemistry, manufacturing, and controls writers and authorship
  • 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.

• Cross-Functional Collaboration & Stakeholder Management:
  • 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.

• Regulatory Risk Management & Compliance:
  • 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.

• Team Leadership & Development:
  • 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.

• Market Access and Competitive Intelligence:
  • 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.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• 10 - 15% domestic and international travel required.

EXPEREINCE AND REQUIRED SKILLS:

• Education:
  • 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.

• Experience:
  • 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..

• Skills & Competencies:
  • 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.

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity 

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.