Senior Director, US Regional Regulatory Lead

SERVIER MONDE • Boston, MA

1d • Hybrid

About The Position

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. As 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.

Requirements

• BS/BA in a relevant scientific discipline required
• Minimum of 12 years of experience working in Regulatory Affairs or related field.
• Previous experience as a global or US regulatory lead required
• Must have prior experience leading multiple FDA meetings
• Capable of independently formulating strategy recommendations with minimal input from manager
• Demonstrated experience leading US IND’s, NDA’s or BLA’s
• 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

Nice To Haves

• Advanced degree (PhD, MD, or MS) in a related field such as life sciences, pharmacy, or regulatory affairs strongly preferred
• experience in oncology and/or neurology therapeutic areas preferred
• Previous experience conducting due diligence assessments preferred
• Prior supervisory experience preferred

Responsibilities

• Collaborate 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 best.
• As regulatory subject matter expert, advise peers.
• Shape 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 plans.
• Provide US regulatory assessment for due diligence opportunities.
• May support managing workload distribution across the US Regulatory Affairs team.

Benefits

• 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
• Short-Term and Long-Term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior