Eli Lilly and Company

Biotexnologiya Farmatsevtika mahsulotlari Sog‘liqni saqlash

Eli Lilly and Company retsept bilan beriladigan dori vositalarini kashf etish, ishlab chiqish, ishlab chiqarish va tijoratlashtirishga e’tibor qaratadigan ko‘p millatli farmatsevtika va sog‘liqni saqlash kompaniyasidir. Uning faoliyati diabet, onkologiya, immunologiya, nevrologiya va og‘riq kabi terapevtik yo‘nalishlarni qamrab oladi hamda tadqiqot va ishlanmalarni klinik sinovlar, tartibga solish jarayonlari, biologik va kichik molekulali dori vositalarini ishlab chiqarish hamda global tarqatish bilan birlashtiradi.

Kompaniyadagi ish o‘rinlari

Senior Director, European Regulatory Strategy

Lead European regulatory strategy for cleminorexton and other development programs, guiding submissions and health authority engagement. The role covers pediatric strategy and regulatory activities across the EU, UK, Switzerland, and other applicable regions.

3 kun oldin

Buyuk Britaniya

160 500 $ – 259 600 $ / yil

Masofaviy To‘liq stavka Senior Talab Qilinadigan Til: inglizcha Muvofiqlik

Tavsif

Act as European Regulatory Lead for cleminorexton and other assigned development programs.
Shape and deliver product registration strategies across the EU, UK, Switzerland, and other applicable regions.
Direct the preparation and submission of MAAs, CTAs, pediatric filings, briefing documents, and related regulatory materials.
Represent the company in engagement with the EMA, EU national authorities, MHRA, Swissmedic, and other European health agencies.
Advise cross-functional program teams on EU regulatory matters and strategy.
Direct pediatric development and submission work outside the United States.
Maintain compliance with applicable European and international regulatory guidance and requirements.
Keep stakeholders informed about regulatory changes and their implications.
Work with Regulatory Affairs leaders to build departmental expertise and improve operations.
Select and manage external EU regulatory consultants and service providers.
Coordinate with global regulatory colleagues to align European plans with activities in other regions.

Talablar

Hold a bachelor's degree in a scientific field.
Bring at least 12 years of progressively responsible regulatory affairs experience in pharmaceuticals or biotechnology.
Have at least 5 years in a regulatory leadership position with substantial European experience.
Demonstrate substantial experience leading European regulatory strategies and submissions.
Demonstrate substantial experience with EU pediatric regulatory strategy and submissions.
Bring recent, substantial experience shaping EU submission strategy, structure, and content for MAAs, CTAs, pediatric submissions, briefing documents, and other European filings.
Show a record of successful engagement with the EMA, EU national authorities, MHRA, Swissmedic, and other relevant health authorities.
Have led development and registration-stage programs as the European Regulatory Lead in a matrix organization.
Have broad knowledge of nonclinical and clinical drug development, ICH guidance, and the requirements and guidance of the EMA, EU national authorities, MHRA, Swissmedic, and other applicable international regulators.
Have led cross-functional teams and provided strategic regulatory direction from early development through registration and lifecycle management.
Communicate effectively in writing, verbally, in presentations, and through stakeholder influence.
Bring strong analytical, problem-solving, organizational, negotiation, and decision-making abilities.
Work effectively in a fast-moving, innovative setting, supporting collaboration, open communication, and stakeholder alignment.
An advanced degree (PhD, PharmD, MS, or JD) and small-molecule development experience are preferred.
CNS experience is strongly preferred.
Experience with regulatory filings and health authority engagement in Japan and/or China is a plus.
Have experience working with a US-based Global Regulatory team and cross-functional partners.

Imtiyozlar

Company bonus, based partly on company and individual performance.
Company-sponsored 401(k) plan.
Pension.
Vacation benefits.
Medical, dental, vision, and prescription drug coverage.
Flexible benefits, including healthcare and/or dependent care flexible spending accounts.
Life insurance and death benefits.
Certain paid time off and leave of absence benefits.
Well-being offerings, including an employee assistance program, fitness benefits, and employee clubs and activities.