Global Regulatory Lead

Job#: 3056987

Location: Remote

The Regulatory Specialist provides strategic regulatory leadership for a late-stage cardiovascular development program, serving as the primary regulatory lead for a key investigational asset. This role drives global regulatory strategies through critical development and registration milestones, including NDA preparation, submission, and review activities. The successful candidate will leverage a strong background in cardiovascular drug development to lead complex matrix teams and navigate key regulatory pathways.

• Serve as the regulatory lead for a late-stage cardiovascular development program, establishing and executing global regulatory strategies.
• Provide strategic leadership throughout key development milestones, including Database Lock, NDA preparation, and submission activities.
• Lead and facilitate internal and joint regulatory teams, driving collaboration, decision-making, and execution across partner organizations.
• Drive regulatory readiness and execution for original NDA submissions, ensuring cross-functional alignment and risk mitigation.
• Develop product registration strategies and translate them into actionable operational plans.
• Develop and execute asset-specific health authority engagement strategies, leading interactions with global regulatory agencies.
• Serve as a regulatory subject matter expert, providing strategic guidance on agency communications and submission approaches.
• Collaborate with clinical, nonclinical, biostatistics, and development teams to ensure regulatory considerations are incorporated into program plans.
• Provide strategic regulatory input to Clinical Study Protocols, Clinical Study Reports, and nonclinical summaries.
• Contribute to the development of Target Product Profiles, Company Core Data Sheets, and global labeling strategies.

• Education: A PhD, MD, PharmD, MS, or BS in a relevant scientific discipline.
• Experience: Significant experience in Regulatory Affairs, typically 4 or more years, with a proven track record supporting cardiovascular drug development programs.
• Technical
  
  Skills:
  
  Prior experience serving as a Global Regulatory Lead, with demonstrated experience leading major regulatory submissions and health authority interactions. Global regulatory experience spanning multiple regions, such as the European Union, Japan, Australia, and other countries.

• Proven success developing and implementing global regulatory strategies that support clinical development and product registration.
• Strong experience communicating regulatory strategy, risks, and recommendations to senior leadership and cross-functional stakeholders.
• Demonstrated ability to lead complex matrix teams across multiple functions and geographies.
• Proven success negotiating regulatory objectives with global health authorities.

• medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection.
• ESPP (employee stock purchase program)
• 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure.
• HSA (Health Savings Account on the HDHP plan)
• Support Linc Employee Assistance Program (EAP) with up to 8 free counseling sessions
• corporate discount savings program and other discounts
• on-demand training program
• certification prep
• library of technical and leadership courses/books/seminars once you have 6+ months of tenure
• certification discounts and other perks to associations that include CompTIA and IIBA
• dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a…