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Manager, Regulatory Lead

it.alfasigma.com Logo

Alfasigma

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Location:
Italy , Bologna

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Category:

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

This position represents one or more Regions / Countries on the Regulatory Sub team and supports the creation/maintenance of Regional Regulatory Strategy as part of the Global Regulatory Strategy for no more than one low complexity program/single asset. The manager works under supervision and provides regulatory support to Clinical Operations and Clinical Development for various activities relating to clinical study start-up and execution, including document review, IND/CTA approval, etc.

Job Responsibility:

  • Contribute to development and local/regional implementation of regulatory strategies for a low complexity program/single asset
  • Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies
  • Contribute to regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, and annual reports to ensure content and format meet all regulatory requirements
  • Contribute to development of regulatory submission plans
  • Assist with coordination and submission of locoregional IND/CTA submissions and maintenance activities
  • Support product development and lifecycle management activities
  • Support assessment of 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
  • 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

Requirements:

  • Bachelor’s degree (minimum 5 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D
  • minimum 3 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research
  • Experience supporting and/or leading IND/CTA submissions
  • Understanding of the cross functional drug development processes (Clinical Operations, Data Management, Biostats, and Regulatory)
  • Strong verbal and written communications skills
  • Excellent project and/or program management skills
  • Detail-oriented and ability to achieve results across functions and levels
  • Ability to work effectively across a highly complex, fast paced, matrix organization
  • Proficiency in MS Office Suite
  • Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
  • Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
What we offer:
  • competitive salary
  • comprehensive benefits
  • extensive opportunities for professional growth and development

Additional Information:

Job Posted:
March 21, 2026

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