Sr. Principal Scientist/Advisor Global Regulatory CMC-Commercial Product/Post Approval Scientist

BioSpace; Indianapolis (IN); On-site; USD 101,000 - 149,000; Full time

Job summary

A leading healthcare company is seeking a Sr. Principal Scientist/Advisor in Global Regulatory Affairs focused on post-approval for commercial products. Ideal candidates will have a strong background in CMC, regulatory strategies, and significant experience in the pharmaceutical industry. This role is essential for ensuring timely regulatory submissions and maintaining product lifecycle strategies.

Benefits

Comprehensive benefits program

401(k) and pension plan

Vacation benefits

Health and wellness benefits

Qualifications

• BSc or higher in Chemistry, Pharmacy, or related field.
• 3-5 years regulatory CMC experience.
• Deep technical knowledge in drug product development.

Responsibilities

• Drive regulatory strategies for product submissions.
• Develop global CMC regulatory strategies.
• Provide regulatory guidance to CMC teams.

Skills

Technical knowledge of solid oral products

Knowledge of global CMC regulatory requirements

Regulatory guidance

Leadership

Communication

Education

Bachelor’s degree or higher in science or engineering

Job description

Sr. Principal Scientist/Advisor Global Regulatory CMC-Commercial Product/Post Approval Scientist

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Sr. Principal Scientist/Advisor Global Regulatory CMC-Commercial Product/Post Approval Scientist

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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 Lilly, we create medicines that give people new hope – to get better, feel better, live better. It’s our purpose to create medicines that make life better for people around the world. Lilly is looking for post approval regulatory CMC (Chemistry, manufacturing and controls) scientists to join us in delivering life-changing new medicines to patients who need them all over the world.

The Sr. Principal Scientist or Advisor Post Approval Scientist in Global Regulatory Affairs – CMC Commercial Products will leverage CMC technical knowledge and regulatory science expertise to drive regulatory strategies and develop post approval and lifecycle regulatory strategies and submissions for Lilly’s commercial products. The scientist will be expected to leverage innovative regulatory strategies that support the lifecycle of assigned product(s).

Key Responsibilities

• Deep technical knowledge of solid oral products CMC science and manufacturing processes.
• Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes and updating global product registrations.
• Develop and evaluate global CMC regulatory strategies in collaboration with other regulatory, manufacturing, quality and project personnel to enable timely completion of submission milestones leading to health authoring approval.
• Development of regulatory strategy and update strategy based upon global regulatory changes.
• Provide regulatory guidance to allow CMC teams to make informed decisions on global registrations and product lifecycle planning.
• Anticipate and resolve key technical or operational issues that could impact the function, CMC team and/or submission timing.
• Take on and independently manage challenging projects and identify creative and/or alternative solutions that support functional and partner organization requirements.
• Take a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval changes, line extensions or renewals, and responses to questions.
• Make decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.
• Engage in site-specific regulatory activities to ensure maintaining registered commitments at the manufacturing site(s) for which they have responsibility for.
  
  
  

Basic Qualifications/Requirements

• Bachelor’s degree or higher degree in science or engineering (Chemistry, Pharmacy or Pharmaceutics, Analytical Sciences, Biology, Biochemistry or Chemical Engineering)
• Minimum 3-5 years of regulatory CMC and/or 7 years of technical proven experience in a similar role or position in oral solid product development, commercialization or manufacturing.
  
  
  

Additional Skills/Preferences

• Fully bilingual (English/Spanish)
• Demonstrated deep technical knowledge and experience of small molecule drug product development, commercialization and manufacturing processes.
• Prior regulatory CMC experience supporting commercialization and/or post-approval submissions for small molecule drug products, or equivalent combination of technical and regulatory guidance knowledge.
• Knowledge of major market procedures, regulations, and practices. Awareness of evolving global regulatory initiatives is desirable.
• Experience planning for and/or participating in Health Authority meetings.
• Demonstrated ability to assess and manage risk in a highly regulated environment.
• Demonstrated strong written, spoken and presentation communication skills.
• Demonstrated leadership behaviors and negotiation and influence skills.
• Demonstrated attention to detail
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.
• Strong compliance mindset and sound judgment
  
  
  

Additional Information

• Position Location: Puerto Rico. Remote option not available.
• Travel: minimal within the US
• Salary will be commensurate with experience
  
  
  

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$101,250 - $148,500

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.

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