Director, US Regional Regulatory Lead

About Servier

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

As a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead, the Director, US Regional Regulatory Lead (US RRL) contributes to innovative, label focused, aligned US and global development plans. The Director, US RRL is accountable to provide US regulatory strategy leadership, leveraging their expertise on US expedited pathways, knowledge of US regulatory precedents and changes in the US regulatory environment. The Director, US RRL interprets and assesses the impact of current US FDA guidance documents and FDA initiatives.

Primary Responsibilities

• Contributes to the GRT for assigned projects in alignment with the team’s one regulatory voice, providing strategic input on the Target Product Profile (TPP), Company Core Data Sheet (CCDS), business planning, governance, and committees.
• Accountable for US regulatory strategy including clinical regulatory strategy to leverage expedited pathways and FDA initiatives.
• Accountable for developing FDA engagement and interaction plans for assigned products, including leading content strategy for briefing documents and information requests, leading the team through meeting preparation and moderating the meeting itself.
• Synthesizes and communicates the impact of FDA program-specific feedback as well as policy and guidelines.
• Contributes to innovative approaches that accelerate drug development and leads the IND/NDA/BLA submission strategy to ensure FDA requirements are met.
• Continually identifies business process gaps that require new or revised processes (and SOP’s) to improve the efficiency of achieving regulatory affairs objectives.
• Collaborates and plays as a team member, aligning team members around shared goals and  enabling each member to contribute their best
• As regulatory subject matter expert, provides helpful guidance to peers
• Shapes and informs the development of global regulatory product strategy.
• Oversees the filing and maintenance of applications such as INDs, BLAs, and NDAs.
• Champions operational and compliance activities for assigned deliverables.

Education and Required Skills

• BS/BA in a relevant scientific discipline
• Advanced degree (PhD, MD, or MS) in a related field such as life sciences, pharmacy, or regulatory affairs preferred
• Minimum of 10 years of experience working in Regulatory Affairs or related field.
• Previous experience as a global or US regulatory lead required and experience in oncology and/or neurology therapeutic areas preferred
• Must have prior experience leading multiple FDA meetings
• Capable of independently formulating strategy recommendations with minimal input from manager
• NDA/BLA filing experience is a plus
• Strong regulatory strategy leader skilled at working with cross-functional and regulatory teams
• Knowledgeable in ICH, FDA guidelines and requirements
• Well organized, scientifically driven, detailed oriented, pragmatic
• Open minded, respectful and excels at teamwork
• Self-directed, solution oriented, excellent at critical thinking and problem-solving

• Comfortable with and capable of prioritizing multiple tasks, projects, and objectives
• Able to exercise discretion and confidentiality in a consistent and professional manner

Travel and Location

• Some travel is required (10%) domestic and international
• Hybrid in-office in Boston or 100% Remote, US East Coast

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Salary Range

The salary range for this role is $198,000 – $240,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).  For more information on our benefits, please visit this link.