Descrizione dell'offerta
Head of Global Labeling and Regulatory Policy
In this global role you will define and drive labeling strategies and regulatory policy for the Innovative Rx portfolio at Alfasigma. You will lead governance for core labeling data and ensure alignment with worldwide requirements to accelerate development and commercialization. You will shape policy through engagement with authorities and industry groups, while advancing digital labeling and data transformation. You will build and lead a cross‑functional team, fostering a ONE‑team culture focused on patients. This is a strategic opportunity to influence global labeling at scale and to enable innovative, compliant product delivery.
- extensive opportunities for professional growth and development
- Define and implement global labeling strategies for the Innovative Rx portfolio and manage governance like Global Labeling Committee
- Monitor and translate global regulatory trends into internal policy and guidance
- Oversee end‑to‑end labeling processes (CCDS, lifecycle updates) across products
- Represent the company in interactions with health authorities, trade associations, and working groups
- Drive adoption of digital labeling solutions (e‑labeling, structured content, IDMP/SPOR, UDI) and ensure data integrity
- Establish global standards, SOPs, and governance to harmonize labeling/regulatory processes
- Collaborate with Development, Quality, Safety, Supply Chain, Commercial, and Legal across product lifecycle
- Lead and develop a high‑performing team with a One Team mindset to support patients and growth
- 10+ years in regulatory affairs or labeling in pharma or related fields
- Strong knowledge of FDA, EMA, ICH frameworks
- Proven experience in global labeling strategy and policy development
- Experience leading cross‑functional, international teams
- Strong leadership, influencing, and communication skills
- Advanced degree in life sciences, pharmacy, regulatory affairs, or related field (PhD, PharmD, MSc preferred)
Candidatura e Ritorno (in fondo)
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