Jobs

Description

Top three skills for the role:

• Global Tender & Project Management: Leads end-to-end regulatory support for international tenders with full accountability for timelines and deliverables
• Cross-Functional Leadership: Drives alignment and execution across multiple stakeholders, influencing without direct authority
• Regulatory Operations Expertise (Global): Deep knowledge of regulatory documentation, processes, and international requirements (e.g., MDR, global submissions)

We are seeking a highly driven and strategic Senior Regulatory Affairs Specialist to lead regulatory operations with a strong focus on global tender and regulatory affairs letters coordination and execution

• This role is critical in ensuring timely, compliant, and high-quality regulatory deliverables to support international tenders, regulatory letters, and post-approval regulatory activities across multiple franchises.
• The ideal candidate operates with a high degree of independence, demonstrates strong cross-functional leadership, and can manage complex, multi-stakeholder deliverables with minimal oversight.

Key Responsibilities:

Tender Coordination & Execution

• Lead and own end-to-end global tender regulatory deliverables, including regulatory documentation, certifications, and product compliance data
• Serve as the central point of accountability for tender-related regulatory activities across franchises
• Drive alignment and coordinate inputs across SMEs, including international affiliates, manufacturing, quality, packaging, R&D, and labeling teams
• Develop and manage tender trackers, timelines, and governance structures to ensure visibility and on-time execution
• Identify risks, proactively escalate issues, and implement mitigation strategies to ensure tender success and timeliness
• Ensure compliance with regional and country-specific regulatory requirements
• Develop and monitor KPIs and dashboards to track performance and drive continuous improvement

Regulatory Operations & Documentation

• Lead the review, coordination, and tracking of regulatory letters (LoA, PoA, controlled substance letters, evidence of conformance, etc)
• Executes preparation and submission of Certificates to Foreign Governments (CFGs), CFG-NE, COEs in the FDA database
• Provide oversight and quality review of Declarations of Conformity (DoC), DoC templates, and translations, ensuring compliance with MDR and global standards and regulations
• Support translation requests through the translations portal
• Review EU MDR DoC translations for accuracy and consistency
• Ensure adherence to Good Documentation Practices (GDP) across all deliverables
• Executes and tracks addendum labeling requests

 Cross-Functional Leadership

• Act as a key liaison between Regulatory Affairs, Quality, Supply Chain, Legal, and international affiliates to resolve complex regulatory challenges
• Facilitate cross-functional governance meetings and drive decision-making and accountability
• Influence stakeholders and align priorities across multiple functions and geographies

Process Improvement & Governance

• Identify and implement process improvements and automation opportunities within regulatory operations and tender workflows
• Lead and support change management activities, including updates to procedures, templates, and systems
• Maintain and enhance trackers, SharePoint repositories, and documentation systems to improve efficiency

Compliance & Issue Management

• Identify and address compliance risks and quality system gaps
• Support CAPA investigations and remediation activities
• Troubleshoot and resolve regulatory operational challenges impacting deliverables

Qualifications & Skills

• Proven experience in Regulatory Affairs, Regulatory Operations, or international submissions
• Strong experience managing complex, cross-functional initiatives independently
• Demonstrated expertise in global regulatory requirements (e.g., EU MDR, international markets)
• Advanced project management, prioritization, and organizational skills
• Excellent stakeholder management and influencing skills, including the ability to drive alignment without direct authority
• Strong critical thinking and problem-solving capabilities
• Ability to operate with minimal oversight and high accountability for outcomes