CrawlJobs Logo
Alfasigma Logo Alfasigma · IT - Administration

Head of Global Regulatory Affairs CMC

Italy, Bologna · Job Posted May 31, 2026
Apply Position
Job Link Share

Job Description

This position is responsible for defining and executing global regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) across the product lifecycle. This position ensures robust regulatory CMC strategies, submission generation, compliance, and alignment with global health authority expectations for pharmaceutical and biologics products. The position plays a critical role in enabling product development, approvals, and lifecycle management through strong scientific, regulatory, and operational leadership.

Job Responsibility

  • Define and lead global regulatory CMC strategies and execution for development, registration, and post-approval lifecycle management, leveraging frameworks such as RELIANCE where appropriate
  • Ensure alignment of CMC regulatory approaches with overall product development and commercialization strategies, partnering cross-functionally to ensure aligned approach
  • Provide strategic input into critical development milestones (e.g., IND/CTA, BLA/NDA, MAA)
  • Oversee the development of high-quality CMC regulatory dossiers, including Module 3 content and supporting documentation, including rigor in CMC regulatory justifications, control strategies, comparability, and specifications
  • Ensure alignment with ICH guidelines and evolving regulatory science expectations, proactively communicating these and their impact for Alfasigma across the organization
  • Lead regulatory support for manufacturing changes, site transfers, scale-ups, and technology transfers
  • Serve as the senior regulatory CMC representative in interactions with global health authorities (e.g., FDA, EMA)
  • Establish global frameworks for CMC change management, ensuring compliance and minimizing regulatory risk
  • Drive efficient handling of complex changes (e.g., process improvements, new technologies, dual sourcing)
  • Ensure global alignment and consistency across markets
  • Drive continuous improvement, standardization, and efficiency across regulatory CMC processes
  • Champion digital transformation in CMC regulatory (e.g., structured content, submission systems, data standards)
  • Ensure data integrity and effective use of regulatory information management systems (RIM)
  • Drive the spirit of 'ONE Team' across all functions by supporting a team approach to focus on our patients as our top priority
  • Build a strong team and continuously grow the individual team members to create and maintain Fit-for-Future capabilities

Requirements

  • 15+ years of experience in regulatory affairs with strong focus on CMC
  • Deep expertise in global CMC regulatory requirements (FDA, EMA, ICH guidelines)
  • Proven leadership of global teams and complex regulatory programs
  • Demonstrated success in major filings and global product approvals
  • Advanced degree in chemistry, pharmacy, chemical engineering, or related scientific discipline (PhD preferred)
  • Strategic regulatory leadership and decision-making
  • Deep CMC scientific and technical expertise
  • Strong understanding of pharmaceutical manufacturing processes
  • Health authority interactions and relationship management
  • Proven ability to be hands-on, agile and lead organizational efforts and innovation by example
  • Strong verbal, written, and technical communication skills
  • Learning agility and 'scalability' to take on increasing responsibility as Company grows
  • Ability to work effectively across a highly complex, fast paced, matrix organization
  • Understanding of the legal and compliance environment
  • Influential and motivating
  • Digital mindset and data-driven leadership
  • Advanced functional experience with MS Office Suite

What we offer

  • competitive salary
  • comprehensive benefits
  • extensive opportunities for professional growth and development
Alfasigma - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Head of Global Regulatory Affairs CMC

8 matching positions

Head of Global Regulatory Affairs, CMC Small Molecule

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-po...
Location
Location
United States , Morristown
Salary
Salary:
232500.00 - 335833.33 USD / Year
sanofi.fr Logo
Sanofi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 10-15 years of direct Regulatory CMC experience preferred
  • Demonstrated progression in regulatory affairs roles and successful regulatory authority interactions
  • Global Leadership experience with a mid-size/large Regulatory CMC organization
  • Strong knowledge of key Agency/Industry thinking, trends and regulations / guidelines
  • Bachelor's degree required
  • Advanced degree (Masters, PhD) in a science or health field (i.e., Analytical, Chemistry, Pharmacy, Biological / Biotechnology Sciences, etc.), or equivalent is highly desirable
  • Demonstrated excellent communication and influencing skills internally and externally
  • Demonstrated ability to assess regulatory risks, identify opportunities, and develop pragmatic solutions that align with business objectives
  • Experience building and maintaining effective partnerships across functions and with external stakeholders, including health authorities
  • 20% travel expected, domestic and international
Job Responsibility
Job Responsibility
  • Provides Leadership to their group and is accountable for organizational design, people development, resource allocation, and metrics
  • Oversees the development of CMC regulatory strategy and regulatory risk assessments for all development projects and marketed products
  • Assures that positive and collaborative relationships are developed with CMC and Device teams
  • Oversees strategic negotiations with worldwide Regulatory Agencies, including directly with FDA and EMA
  • Oversees the preparation review and approval of Regulatory CMC submissions
  • Provides a vision and leadership for Policy and Regulation to assure that appropriate Sanofi representation in external activities is achieved
What we offer
What we offer
  • High-quality healthcare, prevention and wellness programs
  • At least 14 weeks’ gender-neutral parental leave
  • Fulltime
Read More
Arrow Right

Head of Quality Regulatory

The Quality Regulatory department serves as the strategic bridge between regulat...
Location
Location
Mexico , Toluca
Salary
Salary:
Not provided
sanofi.fr Logo
Sanofi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven track record in pharmaceutical regulatory affairs and quality management with demonstrated leadership in managing complex regulatory compliance programs
  • Strategic thinking, executive presence, strong leadership and team development capabilities, excellent stakeholder management, decision-making under pressure, change management expertise
  • Deep expertise in regulatory affairs, quality systems, chemistry manufacturing and controls documentation, global regulatory submissions, audit management, and pharmaceutical regulations across multiple markets
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific field
  • advanced degree preferred
  • Fluency in both Spanish and English is mandatory
Job Responsibility
Job Responsibility
  • Lead regulatory compliance strategy ensuring alignment between approved registrations and site operations
  • Drive market authorization activities worldwide, including territory extensions, transfers, and post-license commitments
  • Oversee batch release processes and ensure timely product submissions and approvals
  • Lead preparation and execution of global quality audits and regulatory inspections
  • Manage internal and supplier audit programs from planning through follow-up
  • Direct change control assessments and define regulatory strategies with cross-functional teams
  • Oversee CMC documentation and dossier preparation for regulatory submissions
  • Lead semi-annual quality performance reviews and site quality planning
  • Drive implementation of quality maturity frameworks and continuous improvement initiatives
  • Build and develop a high-performing Quality Regulatory team
Read More
Arrow Right
New

Business Analyst - Level 3

A Federal Government client requires a Level 3 Business Analyst to lead the requ...
Location
Location
Canada , Gatineau
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
August 02, 2026
Flip Icon
Requirements
Requirements
  • 10 years of professional experience as a Business Analyst in an IM/IT environment
  • Completion of a post-secondary program related to Information Technology of at least 12 months in duration
  • Must hold a valid business analysis certification from an internationally recognized organization
  • Must hold a valid Reliability Status security clearance
Job Responsibility
Job Responsibility
  • Provide verbal Call Center as a Solution (CCaaS) technical and call centre business related recommendations on how to align the written artifact to existing CCaaS, WFM (Workforce Management), WLM (Workload Management) requirements and target contact centre end states
  • Review technical and/or business written artifacts, to provide commentary on possible technology and contact centre operations risks with suggested mitigations
  • Offer executive support and strategic direction for project activities, including managing timelines, while providing guidance, coaching, and coordination to staff in performing essential business analyst tasks
  • Defining and tracking the business requirements and delivery in Azure DevOps, advancing work on target state architecture design and integration options for CCaaS
What we offer
What we offer
  • Remote Work
  • High Impact Modernization: Contribute to a major federal transformation initiative affecting millions of Canadians
  • Strategic Visibility: Provide executive-level support and strategic recommendations directly to leadership
  • Collaborative Environment: Work within self-organizing, cross-functional teams utilizing Agile methodologies and cloud technologies
Read More
Arrow Right
New

Intermediate Technology Architect

We are seeking a highly accomplished and technical Intermediate Technology Archi...
Location
Location
Canada , Peterborough
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
August 02, 2026
Flip Icon
Requirements
Requirements
  • 8+ years of dedicated experience in the design and/or support of P25 radio technology, preferably operating within a Motorola environment
  • 5+ years of experience in a supervisory or leadership capacity managing and administering a P25 radio network
  • Hands-on experience with voice and data encryption configurations (e.g., Key Management Facility / KMF, KMF workstations, and Key Variable Loaders / KVL) paired with software mastery over Motorola ZoneWatch, Provisioning Manager (PM), and Unified Event Manager (UEM) or equivalent tools
  • Demonstrated technical depth in IP networks, telephony, satellite systems, and the design/implementation of massive public sector telecommunication networks
  • Ability to successfully obtain and maintain a high-level public safety security screening (OPP Level 4 Security Clearance)
  • Proven project management skills with a clear ability to organize, schedule, delegate, and review the architectural outputs of downstream teams
  • Strong knowledge of systems development lifecycles, Information Management principles, and designing operational processes around the ITIL methodology
  • Experience using Computer Aided Software Engineering (CASE) tools to author architectural blueprints, physical processes, and data models
  • Exceptional written and verbal communication skills, with a track record of translating complex technical concepts simply to lay audiences
  • Strong interpersonal and negotiation skills to resolve project direction conflicts and build alignment across Business Analysts, stakeholders, and external partners
Job Responsibility
Job Responsibility
  • Develop, recommend, and manage cross-platform technical architectures—including hardware, software, and communications protocols—within large, distributed system environments
  • Oversee the structural configuration, provisioning, and monitoring of high-tier Land Mobile Radio Networks (LMRN) and complex IP communication networks
  • Lead public safety encryption architecture initiatives, managing advanced voice and data encryption infrastructure to safeguard enterprise systems
  • Conduct comprehensive systems analysis, design technical documentation, and build data models or enterprise architecture deliverables to establish robust development environments
  • Organize, schedule, delegate, and review the work of project personnel, providing strong technical leadership and mentoring team members on best practices
  • Translate high-level business needs into technical designs and concise reporting metrics, ensuring alignment with ITIL frameworks and structured governance processes
  • Proactively troubleshoot system bottlenecks, complete technology risk reviews, and deliver fact-based, succinct recommendations to project leadership to build consensus
  • Fulltime
Read More
Arrow Right
New

2nd Line IT Support

Location
Location
United Kingdom , Swindon
Salary
Salary:
Not provided
sumer.co.uk Logo
Sumer Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Solid experience in a 2nd Line role within a multisite or professional services environment
  • Good working knowledge of Windows and Microsoft 365
  • Comfortable taking calls and working with a ticketing system
  • Strong customer service mindset with clear communication skills
  • Willingness to learn, follow procedures, and escalate issues when appropriate
Job Responsibility
Job Responsibility
  • Deliver 2nd Line troubleshooting for laptops, desktops, peripherals, applications, and performance issues
  • Take and manage support calls and tickets, resolving issues at first contact where possible
  • Communicate clearly with users, providing updates and managing expectations
  • Manage user lifecycle processes, including onboarding, leavers, access provisioning, and permissions updates
  • Configure workstations, profile laptops, and ensure new starters receive an effective technical induction
  • Administer Active Directory and Microsoft 365, including mailbox setup, distribution lists, and security groups
  • Perform routine system checks, patching validation and monitoring activities
  • Maintain accurate documentation for systems, configurations, and support procedures
  • Support technical activities related to vulnerability management and remediation
  • Work with tools such as Sentinel one, Qualys, Mimecast, and Microsoft 365 Security Portal
  • Fulltime
Read More
Arrow Right
New

Senior Business Analyst

We are seeking a highly accomplished Senior Business Analyst for an enterprise-l...
Location
Location
Canada , Toronto
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
August 04, 2026
Flip Icon
Requirements
Requirements
  • Agile Methodology Depth: Extensive experience operating within structured Agile project environments, maintaining backlogs, and running iterative sprint cycles
  • DevOps Tooling Acumen: Direct, practical experience utilizing Azure DevOps for documenting requirements, mapping user stories, and managing delivery timelines
  • Requirement Articulation: Proven track record of writing clean, unambiguous user stories and technical requirements with a demonstrated ability to explain implementation logic effectively to developers
  • Enterprise Architecture Mastery: Minimum of 10 years of experience creating high-level enterprise architecture documentation, including explicit mastery over the Zachman Framework
  • Specialized System Insight: In-depth knowledge of digital vehicle and dealership registration programs, automated mailing modules, and integrated payment gateway platforms
  • Architectural Diagramming: Expert-level capability in producing structural logical and physical artifacts, deployment models, sequence diagrams, and use cases
  • Systems Design Principles: Solid understanding of service-oriented architecture (SOA) design patterns, programming concepts, data modeling, and data flow structures
  • Accessibility Compliance: Comprehensive knowledge of digital web accessibility standards, holding an in-depth understanding of WCAG 2.0 and AODA compliance levels for front-end portals
  • Public Sector Acumen: Prior experience delivering I&IT business analysis services, gating matrix approvals, and project assessments within a structured public sector framework or corporate government setting
  • Consultative Expertise: Elite relationship management, negotiation, and consultation skills, with a track record of building alignment across diverse technical squads and corporate stakeholders
Job Responsibility
Job Responsibility
  • Business Assessment & Scoping: Lead and conduct business analysis activities across varying levels of detail to evaluate enterprise problems, optimize service delivery models, and determine appropriate I&IT solutions
  • Agile Requirements Engineering: Formulate clear, well-defined user stories and functional specifications, bridging communication gaps to explain complex requirements simply to the development team
  • Backlog & Sprint Management: Utilize enterprise backlog tools to structure, prioritize, and manage project user stories, tasks, and agile delivery metrics
  • Architectural Artifact Production: Design and maintain core enterprise architecture blueprints, including logical and physical deployment models, sequence diagrams, data flow diagrams, context models, and wireframes
  • Stakeholder Facilitation: Plan, lead, and facilitate interactive requirement-gathering sessions, JAD workshops, stakeholder interviews, and mock-up reviews with cross-functional business units and subject matter experts
  • Strategic Planning Documentation: Research, analyze, and build complete business cases, cost-benefit analyses, feasibility studies, executive presentations, and concise briefing notes
  • Compliance & Governance: Guide projects through corporate checkpoint frameworks, formal gating matrices, Architecture Review Boards (ARB), and technical compliance evaluations
  • Security & Privacy Engineering: Conduct thorough assessments regarding system security and data privacy parameters, supporting the creation of Threat Risk Assessments (TRA) and Privacy Impact Assessments (PIA)
  • Validation & Traceability: Establish clear project performance measures, compile requirement traceability matrices, and monitor implementation progress to resolve active technical constraints
Read More
Arrow Right
New

Machine Operator - Production

The purpose of the Machine Operator position is to ensure the efficient operatio...
Location
Location
Ethiopia , Dukem
Salary
Salary:
Not provided
unilever.com Logo
Unilever
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of technical college certificate of level III/IV with atleast 3 years of work experience in a related scope
  • Good knowledge of RM/PM/GMP/MMP, line profiles, process parameters, quality parameters of production operations
  • Decent and practical understanding of process parameters, procedures, Safety & quality standards
  • Knowledge of the machine components as well as operation/troubleshooting and maintenance of the various machines in the contributing to the finished goods process
  • Very good understanding and proven track record of managing MUVs and Material wastes
  • Experience with GMP and standard operating procedures
  • Ability to read and interpret technical manuals and schematics
  • Understand AM activity with the good implementation
Job Responsibility
Job Responsibility
  • Ensure that procedures and practice adhere to safety policy of Unilever and legislation
  • Full knowledge of workplace and hazards within it
  • Reduce costs due to waste and minimize impact to health, safety and the environment
  • Oversees pre-start-up machine checks to ensure that the area and equipment is clean and is in a safe condition as per the SOP
  • Operate and monitor production machinery, ensuring all equipment is functioning correctly
  • Perform routine maintenance on machinery, including cleaning, Inspection, lubricating, and replacing worn parts
  • Troubleshoot and resolve equipment malfunctions promptly to minimize downtime
  • Conduct regular quality checks on products to ensure they meet established standards
  • Capture and Monitor all relevant production data and metrics to identify trends and areas for improvement
  • Work closely with engineering, quality assurance, and production teams to ensure seamless operations
  • Fulltime
Read More
Arrow Right
New

Machine Operator - Production

Unilever is currently hiring for Machine Operator, Production. Function: Supply ...
Location
Location
Ethiopia , Dukem
Salary
Salary:
Not provided
unilever.com Logo
Unilever
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of technical college certificate of level III/IV with atleast 3 years of work experience in a related scope
  • Good knowledge of RM/PM/GMP/MMP, line profiles, process parameters, quality parameters of production operations
  • Decent and practical understanding of process parameters, procedures, Safety & quality standards
  • Knowledge of the machine components as well as operation/troubleshooting and maintenance of the various machines in the contributing to the finished goods process
  • Very good understanding and proven track record of managing MUVs and Material wastes
  • Experience with GMP and standard operating procedures
  • Ability to read and interpret technical manuals and schematics
  • Understand AM activity with the good implementation
Job Responsibility
Job Responsibility
  • Ensure that procedures and practice adhere to safety policy of Unilever and legislation
  • Full knowledge of workplace and hazards within it
  • Reduce costs due to waste and minimize impact to health, safety and the environment
  • Oversees pre-start-up machine checks to ensure that the area and equipment is clean and is in a safe condition as per the SOP
  • Shuts down equipment and the area as per the SOP, a proper Asset care as per the standards
  • Operate and monitor production machinery, ensuring all equipment is functioning correctly
  • Adjust machine settings based on production requirements and specifications
  • Perform routine maintenance on machinery, including cleaning, Inspection, lubricating, and replacing worn parts
  • Troubleshoot and resolve equipment malfunctions promptly to minimize downtime
  • Maintain a proactive approach to equipment maintenance by following preventive maintenance schedules
  • Fulltime
Read More
Arrow Right