Non-Pharma Global Regulatory Affairs Manager

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 doubling our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, entered rare and specialty segments, and strengthened both our pipeline and our 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 while expanding our reach across diverse markets.

As we continue to grow, we are seeking a RA Non-Pharma Manager to join our team!

 

Scope of the role

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regulatory documentation and operational activities primarily for moderately to complex projects for non-pharma products assigned, across EU and Rest of World markets. The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager works independently within clearly defined areas and applies regulatory knowledge and organizational skills to support operational excellence.

The role is directly responsible for project success and global compliance by ensuring that regulatory documentation, timelines, and communications are effectively managed within a cross-regional, matrixed environment.

This role operates to ensure timely and high-quality delivery of regulatory submissions and lifecycle management activities.

 

Key Accountabilities

Project Leadership:

• Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects (new internal processes, products etc.).

• Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products.

• Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions.

Regulatory Submissions and Delivery:

• Provide and review regulatory assessments for change controls and product updates.

• Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned.

• Provide critical review of documentation supporting regulatory applications.

• Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities.

• Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees, providing project timelines, milestones and submission plans in coordination with cross-functional stakeholders for assigned products.

• Execute defined regulatory tasks within scope and deadlines under the guidance of the Head.

• Support other relevant assignments as directed by supervisor.

Compliance and Documentation Management:

• Person Responsible for Regulatory Compliance MDR, Art. 15 (b), (c), (d), (e) if applicable.

• Manages content and data in Company system.

• Ensure that all regulatory submissions are developed and maintained according to current SOPs, quality standards and applicable regulatory requirements.

• Maintain accuracy of records in regulatory systems and document management platforms.

Stakeholder Collaboration:

• Liaise with Global Pharmacovigilance for safety issues.

• Liaise with Global QA/Supply Chain/Global R&D for regulatory issues related to finished products/raw materials/supplier assessment.

• Engage with external vendors and consultants to support submission preparation and ensure delivery of expected outcomes.

• Provide regulatory and strategic input during due diligence processes, assessments, and business development, licensing and partnership opportunities related to legacy assets.

• Contribute to audits, inspections and regulatory authority communications for assigned products.