Regulatory Scientist-CMC at Eli Lilly And Company in Indianapolis, Indiana

Job Description:

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 39,000 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.

The Indianapolis Site Regulatory Affairs group in CMC Regulatory Affairs is responsible for ensuring Eli Lilly and Company appropriately reports Chemistry, Manufacturing and Control changes to all global regulatory agencies that are supplied from the Indianapolis manufacturing sites and associated contract manufacturers.  The purpose of the Consultant Scientist role is to provide strategic, tactical and operational direction, in support of Lilly’s marketed portfolio, by developing successful regulatory strategies and submissions globally.  To accomplish this purpose, it is necessary for the Consultant Scientist to develop collegial and mutually productive relationships with CMC customers.  Customers include personnel within the Indianapolis pharmaceutical manufacturing sites (e.g. manufacturing science and technology, quality assurance, production, and supply chain) and personnel at bulk manufacturing sites and contract manufacturers’ whose material is used in Lilly products.  The Consultant Scientist utilizes CMC technical and regulatory knowledge and lessons learned across Global Regulatory Affairs-CMC (GRA-CMC) to drive internal consistency and manage the regulatory change agenda.

Primary Responsibilities:  This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.  Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Regulatory & Scientific Expertise

• Deep technical knowledge of pharmaceutical manufacturing technology and processes (e.g. Experience in Production of Dry Products, Parenteral Products or Active Pharmaceutical Ingredients. Analytical Laboratories, Quality Assurance, Manufacturing Science and Technology)


• Utilizes knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes and updating global product registrations


• Develops global CMC regulatory strategies in collaboration with other regulatory, MS&T, Quality, and project personnel to enable timely completion of submission milestones leading to health authority approval


• Leads preparation, review, and finalization of CMC documents for global regulatory submissions, including submissions for manufacturing changes, new products, line extensions or renewals.


• Maintains regulatory commitments for marketed products.

Influence

• Identifies and escalates CMC regulatory issues impacting product submissions across geographies.


• Networks and gains alignment with CMC customers, central and regional regulatory support and management to resolve complex issues.


• Networks throughout Global Regulatory Affairs, as appropriate, building awareness and alignment on CMC Regulatory strategies.


• Provides regulatory guidance to Global Post Launch Optimization Teams, Change Control Boards, and Technical forums, and implements regulatory strategies that result in successful product updates.


• Incorporates new regulations, guidance, and company positions into Lilly processes/guidelines, tools, and/or training materials


• Contributes to the development and maintenance of internal information sources for CMC Regulatory.

Lead / Partner

• Partners with Manufacturing and Quality organization to obtain appropriate data and technical rationale in support of global submissions.


• Resolves identified global CMC regulatory issues, leveraging internal experts to develop complex regulatory strategies


• Creates and manages timelines for development and execution of CMC submissions, resolving issues and conflicts via management escalation as needed


• Delivers clear communication of risks associated with regulatory submissions or the associated timeline, providing routine status updates to project team and supply chain, as needed.


• Provides regulatory CMC strategy and guidance to CMC teams and to product and program teams for CMC issues


• Proactively identifies areas for continued technical learning required in order to align capabilities with marketed portfolio, and obtains required training.

Minimum Qualification Requirements:

• B.S. Degree in Chemistry, Pharmacy 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 (7-10 years)


• Demonstrated knowledge of CMC regulatory guidances

Other Information/Additional Preferences:

• 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 agreed upon timelines

Additional Information:

Position Location: Indianapolis, IN

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.

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.