Global Head Of Regulatory Operations (Digital) Milano

Global Head Of Regulatory Operations (Digital)
Milano
Lombardia, Milano

Global Head of Regulatory Operations (Digital)Company: Alfasigma

Location: Hybrid working with offices in Milan or Bologna

Alfasigma is a fast-growing, independent, and agile pharmaceutical company with a dedicated focus on consumer health, specialty care, and rare diseases.

We are committed to innovation, excellence, and the well-being of our patients and customers.

Overview: 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.

Key Responsibilities 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. Job requirements Who are you? Extensive experience in the pharmaceutical/biotech industry including time working 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. Experience with regulatory information management, document management, and eCTD publishing software, preferably including Veeva Vault RIM and Lorentz DocuBridge software packages. Experience in systems / process improvement / development and associated change management. Leadership experience with direct reports and matrix organizations highly preferred. Major Skills 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? Alfasigma is a pharmaceutical company, born in 2015 from the merger of two historic Italian companies.

It is among the top five pharmaceutical companies operating in the Italian market and boasts a growing international presence, with branches in 27 countries.

At Alfasigma, we believe in fostering a collaborative and innovative work environment.

We offer a competitive salary, comprehensive benefits, and opportunities for professional growth and development.

Join us and be part of a team dedicated to making a difference in the pharmaceutical industry.

Alfasigma is an equal opportunity employer.

We celebrate diversity and are committed to creating an inclusive environment for all employees. Seniority levelExecutive

Employment typeFull-time

Job functionScience

Industries: Pharmaceutical Manufacturing and Biotechnology Research

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