What are the responsibilities and job description for the Advisor - Global Regulatory Affairs CMC position at Eli Lilly and Company?

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

121,500 - $178,200

We are seeking an Advisor / Senior Advisor for Global Regulatory Affairs CMC to be a part of the Lilly Global Regulatory Group to support global submissions and registrations. As the Project Leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical and operational support for Clinical Trial Applications, Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs – CMC will leverage CMC technical knowledge and Regulatory Science expertise to drive Regulatory CMC strategies and develop submissions for marketing authorizations. The Regulatory Scientist is expected to develop and implement innovative Regulatory Strategies to advance the development of assigned product(S).

Regulatory & Scientific Expertise

Deep technical knowledge of manufacturing sciences and processes
Recognized internally and externally for broad knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes and updating global product registrations
Develops and evaluates global CMC regulatory strategies in collaboration with other regulatory, Manufacturing, Quality, and project personnel to enable timely completion of submission milestones leading to health authority approval
Anticipates and resolves key technical or operational issues that could impact the function, CMC team and / or submission timing.
Provides consultation across global regulatory network to assess CMC regulatory strategies, and provide regulatory and technical expertise, to strengthen submission or minimize risk.
Reviews and approves CMC documents for global regulatory submissions, including submissions for manufacturing changes, new products, line extensions or renewals.
Takes on and independently manages risky (i.e., technically challenging, political) problems and identifies creative and / or alternative solutions that support GRA-CMC objectives and partner requirements.

Influence

Makes technical decisions on CMC regulatory issues, setting new company direction and impacting product submissions across geographies.

Advises CMC customers, central and regional regulatory support, and management on resolve complex issues.

Recognized as model of strong leadership behaviors and provides mentoring to regulatory staff on technical and / or regulatory topics.

Leads strategic initiatives to incorporate new regulations, guidance, and company positions into Lilly processes / guidelines, tools, and / or training materials, while building in efficiencies.

Advises Technical Steering teams and network forums, for the development of complex regulatory strategies

Exhibits strong leadership behaviors and is sought out as a functional mentor within Indianapolis site regulatory and

product support network.

Influences policy and emerging regulations worldwide for CMC issues (internally and externally)

Leads initiatives within industry organization(s), effectively increasing Lilly’s visibility and influence of evolving regulatory positions.

Lead / Partner

Leads communication strategy for affiliates and / or senior management, to manage submission requirements, mitigate risk, and maintain regulatory commitment compliance

Monitors global regulatory news and provides interpretation and internal communication as appropriate

Leads technical and regulatory review forums, to evaluate submission strategy and / or data acceptability. Develops complex global CMC regulatory strategies and networks for alignment across Manufacturing, Quality, GRA, product team(s) and affiliates, as required, to enable timely completion of product registration milestones.

Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval changes, and response to question submissions.

Effectively collaborates with Health Authority CMC reviewers at US FDA during scientific advice meetings or submission review and interacts with global Health Authorities, as required

Attends and / or leads industry forums to increase Lilly’s visibility

Participates in forums that share regulatory information across GRA components

Participates in the development of corporate positions on, and in response to, proposed agency regulations and guidelines.

Minimum Qualification Requirements :

B.S. Degree in Chemistry, Pharmacy, Biology, Biochemistry, or related Science or Bachelor’s with equivalent experience

Pharmaceutical industry experience in a manufacturing environment, e.g., Manufacturing Sciences and Technology, Quality Assurance, Analytical Laboratories, or Manufacturing (7 years)

Prior regulatory CMC experience (minimum 3 years) or equivalent combination of technical and regulatory guidance knowledge

Other Information / Additional Preferences :

Synthetic Peptide / Protein experience preferred

Demonstrated knowledge of CMC regulatory guidance’s

Demonstrated strong interpersonal and leadership skills; ability to interact effectively within group and with customer base

Demonstrated ability to organize and analyze detailed information

Demonstrated ability to identify, drive and support business process improvement initiatives

Demonstrated ability to work independently

Demonstrated strong written and verbal communication skills

Demonstrated ability to understand and apply risk analysis concepts

Demonstrated ability to deliver projects according to agree upon timelines

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https : / / careers.lilly.com / us / en / workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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).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.

WeAreLilly

Salary : $121,500 - $178,200

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Advisor - Global Regulatory Affairs CMC

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