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.

Scope Of The Role

The dynamic and experienced Head of Regulatory Operations (Digital) will shape and lead an effective regulatory information, submission management, and Regulatory Operations organization, including people, processes, and systems, for all development programs and marketed products. 

In addition, the Head of Regulatory Operations will be accountable in partnership with R&D QA for Quality Management, Compliance, and process improvement of Global Regulatory Science (GRS) department.  The Head of Regulatory Operations will support the overall Head of GRS with the operational management of the department

The ideal candidate will possess deep knowledge of US and Europe submission regulations, guidelines, and practices. The individual will have strong leadership competencies and strategic operational perspectives to ensure optimal use of information to support regulatory, development, supply chain, and product release decisions.

Your Role

• Lead and develop a team of regulatory information and submission management professionals, driving excellence in matrix teamwork and excellence in delivery.
• Lead and oversee quality management, compliance and continuous improvement of regulatory processes and systems for Reg Ops / Digital and GRS in partnership with R&D QA.
• Be the business owner of all regulatory systems, including but not limited to, Veeva Vault RIM and associated business processes and procedures.
• Develop, implement, and maintain a data strategy for capturing and mining regulatory information and data, including but not limited to IDMP.
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
• Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients as our top priority

Travel up to 20% may be required, which may include overnight and/or weekend travel

Who are you

• 10+ years of relevant experience in the pharmaceutical/biotech industry.
• 5+ years of which in operational and/or systems roles.
• Experience capturing, managing, curating and dashboarding complex data.
• In-depth knowledge and experience in regulatory eCTD submission planning, publishing, and submission.
• Advanced experience with regulatory information management, document management, and associated software and tools.
• Experience in systems / process change management.
• Leadership experience with direct reports and matrix organizations highly preferred.
• Experience across different sized organizations (pharma, biotech, CRO) preferred.
• Experience working with vendors.
• Ability to identify problems, raise them constructively and work towards finding effective solutions.
• Collaborative team player who works effectively with safety, quality, medical affairs, commercial and other functional leaders.
• Proven ability to be hands-on, agile and lead organizational efforts and innovation by example.
• Strong verbal, written, and technical communication skills.
• Learning agility and ‘scalability’ to take on increasing responsibility as Alfasigma grows.
• Consistent demonstration and embodiment of our company core beliefs: Passion for Innovation; Think Big, Act Small; Learn to Dare; Team Build the Future
• Ability to have fun and thrive in a growing, diverse, and inclusive work environment.

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.