Regulatory Specialist Sr

Regulatory Specialist Sr
Santa Clara CA
12+ months contract to hire
Pay range: $45 - $50/hr on W2

Our Fortune 500 client (One of the world's largest Pharma companies) in Santa Clara CA is looking for hardworking, motivated talent to join their innovative team.

Are you a Regulatory Specialist Sr with a passion for collaborating with multiple teams and an interest in working onsite? Don't wait... apply today!

Role Description

Key Responsibilities
Please find below the 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)

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

Are you interested ? Please click apply button!

If you are not available or if this is not the right role at the moment, please share the job description with your friends and let us know if any of them show interest.

About ManpowerGroup, Parent Company of:  Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.