Regulatory Affairs Expert

Alfasigma; Pomezia; In loco; EUR 40.000 - 56.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive benefits

Career growth opportunities

Descrizione del lavoro

Alfasigma is seeking a Regulatory Affairs Specialist to support local Italian product regulatory strategies, including new MA and lifecycle management. You will prepare dossiers, interact with AIFA, and ensure compliant submissions for local and global brands.

You will collaborate with Quality, Medical Affairs, Market Access, and cross-functional teams, leveraging digital tools to improve efficiency and data integrity. Fluency in English and strong regulatory knowledge are essential.

Competenze

• 2+ years regulatory affairs experience in pharma with focus on Italian and EU guidelines.
• Degree in Pharmacy and Pharmaceutical Chemistry and Technology (CTF) or in Pharmacy, Pharmaceutical Chemistry and Technology, or related life-science.
• Master's Degree in Regulatory Affairs is a plus.
• Good knowledge of registration procedures and dossier preparation for EU and Italy.
• Fluency in English, both written and spoken.

Mansioni

• Manage regulatory activities for assigned Rx and OTC products across their lifecycle, ensuring compliance with Italian and EU requirements.
• Prepare, review and submit regulatory dossiers, including variations, renewals, and MA maintenance.
• Interact with Italian regulatory bodies (AIFA) and other authorities under supervision.
• Support development and approval of promotional materials per regulations and company standards.
• Collaborate with cross-functional and international teams to manage a portfolio of ~10 products.
• Monitor regulatory changes and propose actions to adapt portfolio.
• Leverage digital tools to improve regulatory processes and data integrity.
• Maintain accurate regulatory documentation and ensure audit readiness.
• Contribute to continuous improvement and digital innovation within Regulatory Affairs Italy.

Conoscenze

Regulatory affairs

English fluency

MS Office

Cross-functional collaboration

Attention to detail

Project management

Communication skills

Formazione

Pharmacy degree (CTF)

Regulatory affairs master (plus)

Strumenti

eCTD publishing

Veeva RIM

Document management systems

Descrizione del lavoro

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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 role of Regulatory Affairs supports the Regulatory Strategy for Local Italian Products, both for new Marketing Authorization and Life Cycle Management Applications. The Specialist assures an effective and efficient preparation and setting up of the necessary documentation for the new Marketing Authorizations, Variation and MA renewal applications and for any modification of the dossiers of the MAs already authorized.

Your Role

• Manage regulatory activities for assigned Rx and OTC products throughout their lifecycle, ensuring compliance with Italian and European regulatory requirements.
• Prepare, review and submit regulatory dossiers, including variations, renewals, notifications and maintenance activities, with a particular focus on quality and safety related regulatory variations.
• Under supervision, interact with AIFA and other relevant Italian regulatory institutions, ensuring timely and effective management of regulatory requests and communications.
• Support the development, review and approval of promotional and advertising materials, ensuring compliance with applicable regulations and company standards.
• Manage a portfolio of approximately 10 products, including both local and global brands, collaborating with international and cross-functional teams.
• Monitor and interpret regulatory changes, assessing their impact on the company portfolio and proactively proposing appropriate actions.
• Collaborate closely with Quality, Medical Affairs, Market Access, Pharmacovigilance, Supply Chain, Marketing, Global Regulatory, CMC, Internal and ESO Manufacturing Sites, Artwork Dept. and other internal and external stakeholders to ensure regulatory compliance and successful product lifecycle management.
• Leverage digital regulatory tools and systems to improve efficiency, data quality and regulatory processes.
• Maintain accurate regulatory documentation and databases, ensuring data integrity and audit readiness.
• Contribute to continuous improvement initiatives, promoting digital innovation and process optimization within the Regulatory Affairs Italy function.

Who are you

• At least 2 years of experience in Regulatory Affairs within the pharmaceutical industry with focus on Italian and EU guidelines.
• Degree in Pharmacy and Pharmaceutical Chemistry and Technology (CTF). Degree in Pharmacy, Pharmaceutical Chemistry and Technology or, alternatively, Chemistry, Biology or another relevant life-science discipline.
• Master's Degree in Regulatory Affairs is considered a plus.
• Good knowledge of registration procedures and regulatory dossier preparation, including format, content and applicable in EU and Italy Market.
• Understanding of pharmaceutical regulatory processes and lifecycle management activities.
• Strong attention to detail and problem-solving skills.
• Fluency in English, both written and spoken.
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with electronic document management systems.
• Hands-on experience with eCTD publishing and submission tools; familiarity with Veeva RIM is considered a plus.
• Digital mindset and interest in leveraging digital tools and technologies to enhance regulatory processes.
• Strong collaboration and stakeholder management skills, with the ability to work effectively in cross-functional and international environments.
• Proactive, energetic, and results-oriented attitude, combined with a strong willingness to learn and continuously develop.
• Excellent communication skills, analytical thinking, and open-minded approach.
• Ability to manage multiple priorities and work effectively under pressure.
• Strong team player with the ability to share knowledge and best practices among colleagues.

The compensation range indicated in this job posting represents an estimated average range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, and qualifications, in accordance with applicable EU pay transparency and pay equity requirements.

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.