Advisor -Regulatory Compliance and Post Market

Eli Lilly and Company; Concord (NC); Hybrid; USD 126,000 - 204,600; Full time

Benefits offered by this job

401(k) plan

Medical benefits

Vacation benefits

Well-being benefits

Job summary

A leading pharmaceutical company is seeking an Advisor - Regulatory Compliance and Post Market to provide GMP/GxP support, coordinate product recalls and monitor shortages. The ideal candidate will hold a Bachelor's degree in a scientific field and have over 5 years of experience in regulatory affairs, with strong compliance knowledge and excellent communication skills. This role allows for both remote work and on-site flexibility, offering a competitive salary of $126,000 to $204,600 based on experience, alongside comprehensive benefits.

Qualifications

• 5+ years of relevant industry experience in quality assurance or regulatory affairs.
• Broad knowledge of GMPs and quality systems in pharmaceutical industry.

Responsibilities

• Provide GMP/GxP support across regulatory reporting and inspections.
• Coordinate US product recall and withdrawal activities.
• Support monitoring and reporting of US product shortages.

Skills

Compliance knowledge

Excellent communication

Problem-solving ability

Data-driven approaches

Education

Bachelor's degree in a scientific field

Job description

Advisor - Regulatory Compliance and Post Market

Join to apply for the Advisor - Regulatory Compliance and Post Market role at Eli Lilly and Company.

Position Brand Description

This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (Regulatory Compliance and Post Market Reporting) team. Duties include supporting health authority reporting (FAR, BPDR, OUS requirements), global recall and US recall activities, monitoring and reporting of US product shortages, coordinating product shortage notifications for OUS countries, and updating drug and device establishment registrations for changes as required.

Key Objectives / Deliverables

In this role the individual provides support that they give to the different programs, with a primary focus on compliance support. Other duties will depend on business needs.

Compliance Support

• Lead inspection readiness activities.
• Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes.
• Proficient in the application and use of machine learning and analytical tools to maintain continuous inspection readiness.

US and Global Regulatory Reporting

• Work with numerous stakeholders to ensure HA reporting as required to meet all Global regulations/requirements.

Global and US Recall / Market Withdrawal

• Support coordination of US product recall and withdrawal activities.
• Participate in periodic product withdrawal/recall simulations.
• Consult and train local recall coordinators to assure understanding of the process for product removal.
• Monitor recall activities of partner organizations globally.
• Provide information for use in various periodic reviews or metrics.

Global and US Product Shortage

• Coordinate and execute product shortage reporting for US and OUS, networking with supply chain, global quality leaders, senior management, legal, regulatory, global patient safety, and qualified persons at affiliates.
• Generate, submit and maintain product shortage documentation following local procedure.
• Provide information for use in various periodic reviews or metrics.

Drug and Device Establishment Registration

• Determine information required for drug and device establishment registration for all manufacturers of US marketed products.
• Update registrations for changes as required, including completion of annual registrations.

US Volume Reporting

• Coordinate and execute annual volume reporting for the US.
• Provide information for use in various periodic reviews or metrics.

Personal Development and Shared Learning

• Stay continually aware of current industry trends and regulatory agency interpretations of GMP and other relevant requirements.
• Continue to gain knowledge vital to provide a greater understanding of GxP requirements.
• Participate in applicable external industry groups and forums.

Minimum Requirements

• Bachelor’s degree – Preferred degree in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences.
• Minimum of 5 years relevant industry or health authority experience in areas that may include technical services, manufacturing operations, quality assurance, quality control, or regulatory affairs.

Additional Preferences

• Broad knowledge of GMPs and quality systems for pharmaceutical manufacturing and marketing.
• Expertise in data‑driven approaches to assess site compliance.
• Experience in quality assurance or GxP functions.
• Strong compliance knowledge.
• Excellent communication and presentation skills; ability to deliver constructive feedback.
• Skill in interpreting and applying standards to diverse situations with strong problem‑solving ability.
• Ability to work independently and collaboratively with minimal supervision.
• Significant experience supporting global inspections and compliance programs.

Other Information

• Maintain awareness of regulatory and industry trends to keep corporate standards current.
• Flexibility to effectively prioritize work activities to meet regulated timelines.
• Ability to influence and negotiate with peers, immediate supervisors, site supervision, and executive management.
• Availability to travel (domestic and international) when required (estimated at 25%, may increase).
• Role can be remote or based at any Lilly site/affiliate or corporate headquarters; preference is at a Lilly site/affiliate or headquarters.

Compensation

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 – $204,600.

Full‑time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

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 such as 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).

Equal Opportunity Employer

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. 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), and enAble (for people with disabilities). Learn more about all of our groups.