Pomezia, IT Alanno, IT
Sr Associate, Manufacturing Regulatory - Temporary (12 months contract)
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.
Role Purpose
The Sr Associate, Manufacturing Regulatory Affairs is responsible for supporting regulatory activities within continuous improvement and compliance projects related to products, manufacturing, and analytical processes. The role ensures that all changes are assessed, documented, and managed in compliance with applicable regulatory requirements.
Key Responsibilities
- Assess regulatory impact of changes related to manufacturing sites, processes, and products
- Plan and support activities associated with CMC (Chemistry, Manufacturing & Controls) variations and manufacturing site changes
- Coordinate the collection, review, and organization of GMP documentation required for regulatory submissions
- Draft and review documentation supporting CMC variations and manufacturing changes
- Prepare product-specific regulatory declarations and contribute to Product Quality Reviews (PQRs)
- Collaborate cross-functionally with Quality, Manufacturing, and other relevant departments to ensure alignment on regulatory strategies and timelines
- Support continuous improvement initiatives to ensure ongoing compliance with regulatory standards
Qualifications
Education
- Degree in Pharmaceutical Chemistry and Technology (CTF), Chemistry, or Industrial Chemistry
- A Master’s degree in Regulatory Affairs is considered a strong asset
Experience
- 1–2 years of experience in Regulatory Affairs within pharmaceutical companies, preferably in an international environment
Skills & Competencies
- Fluent in English (written and spoken)
- Good proficiency with standard IT tools and basic statistical analysis
- Strong attention to detail and quality-oriented mindset
- Proactive, results-driven approach with the ability to manage assigned responsibilities independently
- Excellent communication and interpersonal skills
- Ability to work effectively in cross-functional teams
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.