Eli Lilly and Company ir starptautisks farmācijas un veselības aprūpes uzņēmums, kas koncentrējas uz recepšu medikamentu atklāšanu, izstrādi, ražošanu un komercializāciju. Uzņēmuma darbība aptver tādas terapeitiskās jomas kā diabēts, onkoloģija, imunoloģija, neirozinātne un sāpju ārstēšana, apvienojot pētniecību un izstrādi ar klīniskajiem pētījumiem, regulatīvajiem procesiem, bioloģisko un mazo molekulu zāļu ražošanu un izplatīšanu visā pasaulē.
Senior Global Regulatory Lead, Neuroscience – Eli Lilly, Indianapolis
Lead global regulatory strategy for Lilly’s neuroscience medicines throughout development and across their full lifecycle. Oversee FDA submissions and agency engagement while guiding cross-functional regulatory teams.
Amerikas Savienotās Valstis175 500 $ – 257 400 $ / gads
KlātienēPilna slodzeVecākais speciālistsNepieciešamā Valoda: angļuAtbilstībaApraksts
- Own and advance global regulatory strategies and the Regulatory Strategy Document from candidate selection through the end of the product lifecycle.
- Use competitive intelligence, health authority guidance, and product-specific advice to shape robust, forward-looking regulatory strategies.
- Represent regulatory affairs on the GBD and global program team, influence development plans, and resolve regulatory obstacles.
- Align local affiliate regulatory plans with global strategy and business priorities for labeling, risk management, and issue management.
- Oversee US FDA submissions and agency engagement, including INDs, NDAs, and BLAs.
- Ensure communications with FDA clearly present Lilly’s scientific position.
- Develop productive FDA relationships in support of product registration goals.
- Set strategic direction for a cross-functional Global Regulatory Team.
- Encourage open communication, constructive feedback, and ongoing development.
- Share key information to support global strategy execution and learning across functions.
- Represent GRA at stakeholder and governance meetings, and mentor GRA colleagues.
- Develop strategic relationships with external stakeholders.
- Advise on promotional strategy and review press and investor relations materials in partnership with Regulatory Product Communications and Global Marketing.
Prasības
- Bachelor’s degree.
- At least eight years of experience in regulatory affairs and/or drug development.
- In-depth knowledge of global regulatory procedures, evolving reform initiatives, and integrated drug development.
- Demonstrated experience with regulatory submissions and agency interactions in the US, EU, China, and Japan.
- Direct experience in both clinical and CMC regulatory sciences.
- Strong leadership, negotiation, and stakeholder communication skills, including with executive audiences.
- Ability to assess and manage risk in a highly regulated setting.
- Experience in the relevant therapeutic area.
Priekšrocības
- Eligibility for a 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 time-off and leave-of-absence benefits.
- Well-being programs, including an employee assistance program, fitness benefits, and employee clubs and activities.
- Relocation provided.
- Expected travel of 10–15%.