Senior Director, US Regional Regulatory Lead

About ServierServier 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 SummaryAs a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead, the Senior Director, US Regional Regulatory Lead (US RRL) contributes to innovative, label focused, aligned US and global development plans. The Senior 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 Senior Director, US RRL interprets and assesses the impact of current US FDA guidance documents and FDA initiatives.Primary ResponsibilitiesCollaborate with and influence 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.Synthesize and communicate the impact of FDA program-specific feedback as well as policy and guidelines.Drive innovative approaches that accelerate drug development and lead the IND/NDA/BLA submission strategy to ensure FDA requirements are met.Systematically evaluates and resolves business process gaps that require new or revised processes (and SOP's) to improve the efficiency of achieving regulatory affairs objectives.Foster collaboration aligning team members around shared goals and enabling each member to contribute their bestAs regulatory subject matter expert, advise peersShape and inform the development of global regulatory product strategy.Oversee the filing and maintenance of applications such as INDs, BLAs, and NDAs.Champion operational and compliance activities for assigned deliverables.Anticipate regulatory and competitive environment evolution and translate it into opportunities for expedited clinical development plansProvide US regulatory assessment for due diligence opportunitiesMay support managing workload distribution across the US Regulatory Affairs teamEducation and Required SkillsBS/BA in a relevant scientific discipline requiredAdvanced degree (PhD, MD, or MS) in a related field such as life sciences, pharmacy, or regulatory affairs strongly preferredMinimum of 12 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 preferredPrevious experience conducting due diligence assessments preferredPrior supervisory experience preferredMust have prior experience leading multiple FDA meetingsCapable of independently formulating strategy recommendations with minimal input from managerDemonstrated experience leading US IND's, NDA's or BLA'sStrong regulatory strategy leader skilled at working with cross-functional and regulatory teamsKnowledgeable in ICH, FDA guidelines and requirementsWell organized, scientifically driven, detailed oriented, pragmaticOpen minded, respectful and excels at teamworkSelf-directed, solution oriented, excellent at critical thinking and problem-solvingComfortable with and capable of prioritizing multiple tasks, projects, and objectivesAble to exercise discretion and confidentiality in a consistent and professional mannerTravel and Location* Some travel is required (10%) domestic and international* Hybrid in-office in Boston or 100% Remote, US East CoastJob DescriptionCandidate ProfileServier's CommitmentServier 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 RangeThe salary range for this role is $232,000 - $284,000. 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.Nearest Major Market: Boston