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 This position is responsible for defining and driving global strategies for product labeling and regulatory policy, across the company. This role ensures that product information, labeling content, and regulatory frameworks align with global requirements while enabling timely product development and commercialization. Your role <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:Calibri, sans-serif">Global Labeling Strategy & Governance: Lead the development and implementation of global labeling strategies for the Innovative Rx portfolio and implement governance (e.g. Global Labeling Committee) to manage changes to Company Core Data Sheets (CCDS) etc..</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:Calibri, sans-serif">Regulatory Policy Leadership: Monitor, interpret, and influence evolving global regulatory frameworks; translate regulatory trends into actionable policies and guidance for internal stakeholders across multiple product categories.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:Calibri, sans-serif">Label Development & Lifecycle Management: Oversee end-to-end labeling processes for Innovative Rx portfolio, including CCDSs, and lifecycle updates (e.g., safety changes, new indications, reformulations).</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:Calibri, sans-serif">Health Authority & Industry Engagement: Represent the organization in interactions with global regulatory authorities, industry associations, and working groups to shape policy and stay ahead of regulatory changes.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:Calibri, sans-serif">Digital Labeling & Data Transformation: Drive the adoption of digital labeling solutions (e.g., e-labeling, structured content, IDMP/SPOR, UDI), ensuring data integrity, standardization, and system integration.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:Calibri, sans-serif">Operational Excellence & Process Harmonization: Establish global standards, SOPs, and governance models to streamline labeling and regulatory processes across regions and product types.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:Calibri, sans-serif">Stakeholder Management: Partner with Development, Quality, Safety, Supply Chain, Commercial, and Legal to ensure alignment across the product lifecycle.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:Calibri, sans-serif">Leadership: Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients as our top priority. Build a strong team and continuously grow the individual team members to create and maintain Fit-for-Future capabilities.</li> </ul> Who are you: <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">10+ years of experience in regulatory affairs and/or labeling in pharma and/or non-pharma industries </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Strong knowledge of global regulatory frameworks (FDA, EMA, ICH) </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Proven experience in global labeling strategy and policy development </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Experience leading cross-functional, international teams </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Strong leadership, influencing, and communication skills</li> </ul> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Advanced degree in life sciences, pharmacy, regulatory affairs, or related field (PhD, PharmD, MSc preferred)</li> </ul> Competencies & Major Skills <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Strategic thinking and policy development</li> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Deep regulatory and compliance expertise</li> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Stakeholder influence and executive communication </li> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Proven ability to be hands-on, agile and lead organizational efforts and innovation by example</li> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Strong verbal, written, and technical communication skills</li> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Learning agility and ‘scalability’ to take on increasing responsibility as Company grows</li> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Ability to work effectively across a highly complex, fast paced, matrix organization</li> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Understanding of the legal and compliance environment</li> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Influential and motivating</li> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Digital mindset and data-driven leadership</li> <li style="margin:0.0cm 0.0cm 0.0cm 1.2px;text-align:justify;line-height:normal;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Advanced functional experience with MS Office Suite</li> </ul> The role is preferably based at one of our Italian locations: Bologna, Milan, or Pomezia. 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.

Head of Global Labeling and Regulatory Policy (Bologna, IT) @ Alfasigma Jobs

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