Manager, Regulatory Lead

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities. But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets. As we continue to grow, we are seeking a Manager, Regulatory Lead. This position will be remotely located on the east coast (EST) of the United States. Scope of the role: This position represents one or more Regions / Countries on the Regulatory Sub team and supports the creation/maintenance of Regional Regulatory Strategy as part of the Global Regulatory Strategy for no more than one low complexity program/single asset. The manager works under supervision and provides regulatory support to Clinical Operations and Clinical Development for various activities relating to clinical study start-up and execution, including document review, IND/CTA approval, etc. Your key responsibilities:

• Contribute to development and local/regional implementation of regulatory strategies for a low complexity program/single asset
• Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies
• Contribute to regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, and annual reports to ensure content and format meet all regulatory requirements
• Contribute to development of regulatory submission plans
• Assist with coordination and submission of locoregional IND/CTA submissions and maintenance activities
• Support product development and lifecycle management activities
• Support assessment of regulatory pathways for submissions to the FDA and other regulatory agencies
• Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards
• Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities

Who are you:

• Bachelor’s degree (minimum 5 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D; minimum 3 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research
• Experience supporting and/or leading IND/CTA submissions
• Understanding of the cross functional drug development processes (Clinical Operations, Data Management, Biostats, and Regulatory)
• Strong verbal and written communications skills
• Excellent project and/or program management skills
• Detail-oriented and ability to achieve results across functions and levels
• Ability to work effectively across a highly complex, fast paced, matrix organization
• Proficiency in MS Office Suite
• Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
• Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity

Why Join Alfasigma: At Alfasigma, we foster a culture where the courage to innovate is key to our success. We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry. Apply tot his job Apply To this Job