Senior Director, Regulatory Affairs Dice

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At DICE Therapeutics (a wholly owned subsidiary of Eli Lilly), we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
Do you have a Regulatory Affairs background with experience in immunology? Apply today to join the Lilly Team!
Responsibilities:

• Be accountable for leading the development of strategic plans for pipeline assets and implementation.
• Provides leadership on project teams in all areas of Regulatory Affairs
• Develop regulatory strategies across multiple regulatory activities (CMC, nonclinical, and clinical) to ensure timelines and achievements are met to support the business needs of the company
• Plan, implement, and lead successful regulatory agency meetings and interactions per regulatory strategy
• Define content for and direct the organization and preparation of high quality and effective regulatory submissions, including future applications (e.g., CTA and IND)
• Review and approve clinical study protocols, informed consent forms, statistical analysis plans, clinical study reports, investigator brochures, responses to regulatory agencies and all regulatory submissions
• Serve as regulatory liaison with global health authorities, business partners, and CROs
• Play a key role as a member of the Development Leadership Team
• Understands and maintain knowledge and monitor changes in pertinent laws, regulations and guidance's and takes a leadership role in assessing and communicating the impact of these requirements to the business

Minimum Requirements:

• PhD, PharmD, MD, or MSc with 8+ years of progressively responsible Regulatory Affairs experience within pharma/biotech industry at a minimum ; OR
• BS with 10+ years of progressively responsible Regulatory Affairs experience within pharma/biotech industry at a minimum

Preferences:

• Experienced global regulatory leader with a proven track record
• Experienced in submitting INDs and in managing international regulatory filings
• Experienced in leading interactions with health authorities such as preIND, EOP2 meetings etc.
• Comprehensive understanding and applied knowledge of global regulatory requirements for the development and approval of investigational products
• Well-developed critical reasoning skills and in risk management assessments
• Experience in immunological therapeutic areas preferred but not crucial
• Experience with line management, professional development, and mentorship of direct reports including providing feedback on employee performance and goal setting
• Possess an entrepreneurial spirit and adaptable to a dynamic environment, with strong leadership and interpersonal skills
• Forward-thinking, self-motivated, articulate and creative, as well as collaborative and analytical
• Strong technical judgment with attention to detail and proactively manages and identifies potential issues/risks and recommends/implements solutions with key internal and external partners
• Proven ability to collaborate across multiple functions and build effective relationships
• Demonstrated excellence in independent management of complex projects
• Strong written and verbal communication skills and presentation effectiveness
• RAC certification also preferred but not required

Additional Information:
Location: San Francisco preferred, remote may be considered.
Lilly currently anticipates that the base salary for this position could range from between $188,000 to $270,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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