Senior Director, US Regional Regulatory Lead

About the role

The Senior Director, US Regional Regulatory Lead (US RRL) contributes to innovative, label-focused, aligned US and global development plans. This role is accountable for US regulatory strategy, including clinical regulatory strategy to leverage expedited pathways and FDA initiatives. The US RRL collaborates with and influences the Global Regulatory Team (GRT) for assigned projects.

Primary 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 evaluate and resolve 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

Education and Required Skills

• BS/BA in a relevant scientific discipline required
• Advanced degree (PhD, MD, or MS) in a related field such as life sciences, pharmacy, or regulatory affairs strongly preferred
• Minimum 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 preferred
• Previous experience conducting due diligence assessments preferred
• Prior supervisory experience preferred
• 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
• 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

Job Description

Candidate Profile

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 $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).