Director, US Regulatory Affairs and Quality Management

About Servier Pharmaceuticals

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision. 

Role Summary

The Director of US Regulatory Affairs and Quality Management at Servier Pharmaceuticals, reporting to the Senior Director of Medical Operations, is responsible for leading post-approval regulatory activities and ensuring compliance with quality standards. This role involves directing regulatory reviews for medical and advertising and promotional (ad/promo) materials for product, disease state, and training/education programs, formulating strategic improvements for the Regulatory Ad/Promotion function, and ensuring timely submissions are made to OPDP. The Director will proactively review regulatory guidelines, assesses phase IV clinical trial design for marketing and medical communication impacts, and evaluate labelling changes. Additionally, the role oversees quality document (QD) management, ensuring global policies adapted for US compliance, conducting gap assessments, proposing process changes, and leading the development of standard operating procedures (SOPs) and associated training. The Director supports Servier’s audit program. This role requires managing direct reports, fostering cross-functional collaboration, and delivering high performance.

Primary Responsibilities

Regulatory Affairs (RA) Responsibilities

• Lead the US Commercial Regulatory Affairs function as Local Regulatory Affairs Responsible Person (LRA)
• Oversee and implement US regulatory strategy and activities for commercialized products
• Provide oversight for RA on various US Committees: Promotional Review Committee (PRC), Medical Scientific Review Committee (MSRC), Investigator Sponsored Studies (ISS) Local Review Committee (LRC) and others requiring commercial regulatory affairs
• Oversee the review and approval of advertising/promotional materials
• Coordinate, prepare, and ensure timely submission to FDA of US advertising and promotional material (FDA Form 2253)
• Serves as the primary contact with key personnel in FDA Office of Prescription Drug Promotion (OPDP)
• Function as US Liaison to Worldwide Regulatory Affairs (WRA) on US regulatory affairs activities and initiatives, including, contributing to proposed product labelling, and ensuring the Company meets the obligations of the NDA and BLA holder as required by Servier global regulatory affairs
• Contribute to due diligence activities and product/company integrations
• Manage batch follow ups of recalls and falsified products
• Review and approve product labelling and other quality documents as requested for reconciliations
• Ensure compliance of US activities with the current regulatory requirements, including the conduct of post-authorization programs, handling of product quality complaints and medical information activities
• Ensure the local regulatory intelligence and impact analysis
• Manage constructive interactions with project team members, consultants, and contractors
• Ensure budgetary and operational goals are met in conjunction with Sr Director, Medical Operations

Quality Management Responsibilities

• Write and/or maintain quality documents, including standard operating procedures (SOP) and department working practices for the US, as identified with Medical Leadership
• Review and approve investigations, deviations, CAPA, product complaints, SOPs, and any technical reports as needed
• Support Servier’s audit program, including audit preparation, coordination, execution, participation in the review of audit reports, and follow up to any findings
• Monitor new and updated Global SOPs for applicability to US quality documents
• Participate in implementing and maintaining the US matrix for employee training on quality documents

Education and Required Skills

• Bachelor’s degree required; advanced degree preferred
• 8+ years professional experience with minimum of 5 years relevant Regulatory Affairs experience in a biotech/pharmaceutical setting; an equivalent combination of relevant education and experience may be considered

• Experience working in the therapeutic area of oncology
• Well-grounded knowledge of regulatory affairs principles, practices, and systems in the areas of marketed products and lifecycle management.
• Experience with regulatory processes, including submission to FDA of US ad/promo documents
• Strong expertise in electronic document management systems, and publishing software and tools
• Knowledgeable in pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance, and documentation
• Experienced in developing and maintaining quality systems and standard operating procedures
• Skilled in project management 
• Demonstrated management and leadership skills
• Self-organized, self-directing, and initiative-taking
• Strong critical thinking and analytical skills
• Effective communication skills, including oral, written and presentation skills
• Excellent interpersonal skills with the ability to work collaboratively in teams and with autonomy

Travel and Location

• Some travel required (~20%)
• Boston-based or remote, with expectation of periodic visits to Boston HQ

Servier’s Commitment

We’re an organization, committed to modeling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description.