Job Description

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.

As we continue to grow, we are seeking Sr. Manager, Early Development Regulatory Lead.

Scope of the role:

This position represents one or more Regions / Countries on the Regulatory Sub team and supports the creation / maintenance of the Regional Regulatory Strategy, as part of the Global Regulatory Strategy, for one or more assigned medium ‑complexity programs / single approved asset and leads its locoregional implementation. The position liaises between Country Regulatory and the asset Global Regulatory Sub team. The Senior Manager operates with limited guidance and oversight and provides regulatory support to Clinical Operations and Clinical Development for various activities relating to NDA/MAA submissions and clinical study start-up and execution, including document review, CTA approval, etc.

Your key responsibilities:

• Support development and locoregional implementation of regulatory strategies for at least one medium‑complexity program (single asset)
• Identify and communicate potential regulatory risks and mitigations to the Regulatory Subteam
• Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies
• Regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, pediatric plans, briefing books, DSURs, annual reports, etc., to ensure content and format meet all regulatory requirements
• Lead coordination of locoregional IND/CTA and/or NDA/MAA submissions and supplements, while managing and partnering with CRO
• Lead development regional regulatory submission plans
• Support product development and lifecycle management activities
• Represent Regulatory Sciences on the Study teams, and assess regulatory pathways for submissions to the FDA and other regulatory agencies
• Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards
• Assume other relevant assignments as assigned
• Provide mentorship and support to colleagues to support their activities and help with the production of appropriate reports and documents.
• Assist Regulatory department in the update and creation of internal policies and procedures
• 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 and customers as our top priorities.

Who are you:

• Bachelor’s degree (minimum 8 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D; minimum 5 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research
• Understanding of/experience supporting and/or leading IND/CTA and NDA/MAA (and supplement) submissions
• Experience overseeing regulatory collaboration with CROs or other partnering organizations and coordinating US and/or international submissions to meet regulatory requirements is desired
• Strong verbal and written communications skills
• Exceptional interpersonal and problem-solving skills
• Excellent project and/or program management skills
• Learning agility and ‘scalability’ to take on increasing responsibility as Company X grows
• Ability to work effectively across a highly complex, fast paced, matrix organization
• Understanding of the legal and compliance environment
• Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
• Advanced functional experience with MS Office Suite

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.

Alfasigma is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee on the basis of race, religious creed, religious observance, color, age, sex, sexual orientation, gender, gender identity, gender expression, genetic information, national origin, ancestry, marital status, medical condition as defined by state law (cancer and genetic characteristics), disability, military service, military and veteran status, pregnancy, childbirth and related medical conditions, or any other classification protected by federal, state, and local laws and ordinances. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on the Company. Please email Human Resources at HR@alfasigma.com if you need assistance completing any forms or to otherwise participate in the application process