Regulatory Affairs Senior Specialist Job at Giza Systems (Western Province)

Global Supplier Quality Senior Specialist

The Senior Specialist, Global Supplier Quality is responsible for driving suppli...

Location

Italy , Pomezia; Milano; Bologna; Alanno

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 7 years’ experience in supplier quality management within pharmaceuticals, medical devices, or food supplements
Strong working knowledge of GMP, ISO 13485, HACCP, and global regulatory expectations
Demonstrated success in supplier audits, risk-based quality management, and compliance oversight
Lead Auditor certification highly desirable
Bachelor’s or Master’s degree in Pharmacy, Chemistry, Engineering, or a related technical field
Proven experience using digital tools and systems for supplier qualification and performance management
Exceptional communication, stakeholder management, and problem-solving skills
Ability to operate effectively in a fast-paced, matrixed, and multicultural environment
Fluency in English required
Strong proficiency with Microsoft Office Suite and other business platforms

Job Responsibility

Lead global supplier qualification, approval, and requalification processes in alignment with corporate and regulatory standards
Develop and maintain comprehensive supplier risk assessments and qualification documentation
Oversee the full supplier lifecycle — from onboarding and performance monitoring to periodic reviews and requalification
Plan, conduct, and report supplier audits (both on-site and remote) to verify compliance with internal and external standards
Ensure adherence to GMP, ISO 13485, HACCP, and other applicable global quality and regulatory frameworks
Partner with suppliers to address audit findings, implement corrective and preventive actions, and monitor their effectiveness
Support site quality operations in reviewing and approving supplier-provided documentation, including change controls, technical files, and periodic reviews
Maintain and update Supplier Quality Agreements, ensuring alignment with internal policies and regulatory requirements
Contribute to the preparation and successful execution of regulatory inspections and customer audits related to supplier management
Proactively identify and mitigate supplier-related risks impacting product quality or supply continuity

Senior Regulatory Affairs Specialist

Reporting to the Senior Manager, Regulatory Affairs within the RA Department, th...

Location

United States , St Louis

Salary:

74000.00 - 90000.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
Self-starter with demonstrated organizational, project management, time management and problem-solving skills
Experience working effectively on cross-functional teams
Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
Excellent PC skills, including Microsoft Office applications including Excel, Word and PowerPoint
Understanding of chemical / scientific industry
Experience with internal audit process and quality systems
Experience with Healthcare regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries

Job Responsibility

Identify regulatory requirements for new products or product enhancements early in the product development cycle
Assure that product registration and maintenance fees are tracked and paid
Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims
Review product revision requests to assure compliance with regulatory requirements
Work on product teams to develop regulatory strategy based on regulatory submission requirements
Review and approve labeling and marketing literature
Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters
Provide Regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries to the Healthcare team
Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management
Other duties as assigned

What we offer

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care

Fulltime

Senior Product Specialist, Regulatory Affairs

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Extensive experience with practical European Regulatory Affairs
Good understanding of MA lifecycle activities within DCP, MRP and National procedures (Post-authorisation variations, submission strategies, renewals, PSURs/PSUSAs)
Knowledge of CTD/eCTD documentation structure and lifecycle management
Knowledge of European regulations and related guidance documents for Regulatory submissions, Product Information authoring, CMC documentation, CTD and eCTD authoring
Able to perform other Regulatory Affairs activities with team support (e.g., PASS, PAMs, Centralised Procedure submissions)
Able to perform accompanying activities such as artwork reviews/approvals and Prescribing Information preparation
Good interpersonal skills and effective problem-solving capabilities
Proactive, adaptable and comfortable working across multiple projects while maintaining high standards
High attention to detail with excellent organisational and time-management skills
Excellent written and verbal communication skills in English

Job Responsibility

Preparation and submission of required regulatory packages for designated products/countries
Authoring/updating of key regulatory documentation including CTD components and Product Information
Development and implementation of regulatory strategy for required changes
Act as the contact within the business for regulatory advice and support related to designated products
Provide support and regulatory advice to key internal stakeholders
Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
Communication with external stakeholders, including regulatory agencies, CMO’s and third party service providers
Creation and maintenance of Regulatory Information Management systems and databases records and entries
Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance

What we offer

25 days holiday + 8 bank holidays
Private Health Insurance for employee and family members
Pension contribution: 10% company + 5% employee (auto-enrolled from day one)
Hybrid Working
Cycle to Work Scheme
Engaging employee experience to come together as a community: in-office events, shared learning and much more

Fulltime

Senior Regulatory Affairs Product Specialist

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Advanced experience with practical European Regulatory Affairs, including a good understanding of the following MA lifecycle activities within DCP, MRP and National procedures (preferably also other than URPL): post-authorisation variations impacting CMC, Safety and Product Information
different submission strategies (e.g. single, grouping, SuperGrouping, WorkSharing)
other RA activities such as renewals and PSURs/PSUSAs
CTD/eCTD documentation structure and lifecycle management
Knowledge and understanding of the following areas, European regulations and related guidance documents (e.g. management of documents, submissions, requirements): regulatory submissions across different markets and procedures, including the Centralised Procedure
Product Information authoring, editing and management
CMC documentation requirements
CTD and eCTD authoring, editing and lifecycle management
Able to perform other Regulatory Affairs activities with team support (e.g. PASS, PAMs, Centralised Procedure submissions)
Able to perform accompanying activities such as Artwork reviews/approvals and Prescribing Information preparation

Job Responsibility

Preparation and submission of required regulatory packages for designated products/countries, including variations and lifecycle activities
Authoring/updating of key regulatory documentation including CTD components and Product Information and leading review of other technical documents to ensure regulatory compliance
Development and implementation of regulatory strategy for required changes
Act as the contact within the business for regulatory advice and support related to designated products
Provide support and regulatory advice to key internal stakeholders including MS&T, Quality, Pharmacovigilance, Supply and other teams
Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
Communication with external stakeholders, including regulatory agencies, CMO's and third party service providers
Creation and maintenance of Regulatory Information Management systems and databases records and entries
Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance

What we offer

A fast-paced environment with broad exposure, giving you opportunities to develop professionally - even outside your core area of expertise
A culture that supports learning, celebrates success, and recognizes performance
Opportunities for driven and talented professionals to contribute to our exciting journey

Fulltime