Senior Associate, Regulatory Affiliate - Backfill (1 Year)

📌 Core Information

🔹 Job Title: Senior Associate, Regulatory Affiliate - Backfill (1 Year)

🔹 Company: Lilly

🔹 Location: Kyiv, Ukraine

🔹 Job Type: Full-Time

🔹 Category: Pharmaceuticals

🔹 Date Posted: July 21, 2025

🔹 Experience Level: 0-2 years

🔹 Remote Status: On-site

🚀 Job Overview

Key aspects of this role include:

• Managing operational and technical aspects of regulatory affairs for the marketing affiliate
• Ensuring compliance with local regulations and quality system requirements
• Fostering relationships with local regulatory agencies and MoH
• Collaborating with cross-functional teams to achieve affiliate regulatory objectives

ASSUMPTION: This role requires a strong understanding of local regulations and regulatory procedures, as well as excellent communication and project management skills.

📋 Key Responsibilities

✅ Execute the Regulatory Plan to ensure the success of new product registration, line extensions, and new indications

✅ Maintain marketing authorizations and ensure timely submission of post-approval maintenance activities

✅ Facilitate and cultivate relationships with local regulatory agencies/MoH

✅ Represent the Regulatory Affairs function in affiliate lead team and new product planning discussions

✅ Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment

✅ Ensure implementation of local quality system in line with the global quality system and local regulations

✅ Perform the function of Primary, Alternate, or Delegate Affiliate Labelling Responsible Person (ALRP)

✅ Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge

ASSUMPTION: This role involves a high degree of responsibility and requires strong organizational skills and the ability to manage multiple projects simultaneously.

🎯 Required Qualifications

Education: Bachelor's degree or equivalent in a relevant scientific subject

Experience: At least one year of industry-related experience in regulatory affairs and experience dealing with external regulatory agencies, the healthcare system, and marketing needs

Required Skills:

• Knowledge of local regulations and regulatory procedures
• Excellent communication skills
• Strong project management skills
• Ability to adapt to challenging situations
• Good computer/IT skills
• Good knowledge of written and spoken English

Preferred Skills:

• Analytical, problem-solving, and negotiation skills
• Good communication skills
• Project management skills
• Strong planning and priority-setting skills
• Good capability to establish positive networking both internally and externally
• Strong knowledge of quality systems

ASSUMPTION: While not explicitly stated, it is assumed that candidates should have a strong understanding of the pharmaceutical industry and regulatory affairs processes.

💰 Compensation & Benefits

Salary Range: The salary range for this role is estimated to be between $40,000 and $60,000 USD per year, based on industry standards for similar roles in the pharmaceutical industry in Kyiv, Ukraine.

Benefits:

• Health, dental, and vision insurance
• Retirement savings plan with company match
• Paid time off and holidays
• Employee assistance program
• Tuition assistance

Working Hours: Full-time, Monday-Friday, 9:00 AM - 5:00 PM (with a 1-hour lunch break)

ASSUMPTION: The salary range provided is an estimate based on industry standards and may vary depending on the candidate's qualifications and experience.

📌 Applicant Insights

🔍 Company Context

Industry: Pharmaceutical Manufacturing

Company Size: 10,001+ employees

Founded: 1876

Company Description:

• Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world
• The company discovers, develops, and delivers medicines that help people live longer, healthier, and more active lives
• Lilly has a strong commitment to improving the understanding and management of disease, and to giving back to communities through philanthropy and volunteerism

Company Specialties:

• Pharmaceutical Development
• Pharmaceuticals
• Biotech
• and Biopharmaceuticals

Company Website: http://www.lilly.com/

ASSUMPTION: Lilly is a well-established company with a strong reputation in the pharmaceutical industry. The company's size and global presence offer opportunities for career growth and development.

📊 Role Analysis

Career Level: Mid-level

Reporting Structure: This role reports directly to the Regulatory Affairs Manager

Work Arrangement: On-site, full-time

Growth Opportunities:

• Potential for career progression within the regulatory affairs function
• Opportunities to work on cross-functional teams and gain exposure to other areas of the business
• possibility to work on global projects and gain international experience

ASSUMPTION: This role offers opportunities for professional growth and development, both within the regulatory affairs function and across the broader organization.

🌍 Location & Work Environment

Office Type: Corporate office environment

Office Location(s): Lilly Corporate Center, Indianapolis, Indiana 46285, US

Geographic Context:

• Kyiv, Ukraine, is the capital and largest city of Ukraine, with a population of approximately 2.9 million people
• The city is known for its historical sites, cultural attractions, and vibrant nightlife
• Kyiv has a humid continental climate, with warm summers and cold winters

Work Schedule: Monday-Friday, 9:00 AM - 5:00 PM (with a 1-hour lunch break)

ASSUMPTION: The work environment at Lilly is professional and collaborative, with a strong focus on teamwork and cross-functional collaboration.

💼 Interview & Application Insights

Typical Process:

• Online application and resume submission
• Phone or video screen with the hiring manager
• On-site interview with the hiring manager and other team members
• Background check and offer

Key Assessment Areas:

• Regulatory affairs knowledge and experience
• Communication and interpersonal skills
• Problem-solving and analytical skills
• Adaptability and flexibility

Application Tips:

• Tailor your resume to highlight your relevant regulatory affairs experience and skills
• Prepare examples of how you have successfully managed regulatory affairs projects or challenges in the past
• Research Lilly and the pharmaceutical industry to demonstrate your knowledge and enthusiasm for the role

ATS Keywords: Regulatory Affairs, Pharmaceuticals, Project Management, Communication Skills, Analytical Skills, Problem Solving, Negotiation Skills, Team Working, Planning, Priority Setting, Networking, Quality Systems, Technical Expertise, Adaptability, Training, Collaboration, Regulatory Compliance

ASSUMPTION: The application process at Lilly is competitive, and candidates should be prepared to demonstrate their relevant experience and skills throughout the interview process.

🛠️ Tools & Technologies

• Microsoft Office Suite (Word, Excel, PowerPoint)
• Regulatory affairs software and databases (e.g., EudraVigilance, ClinicalTrials.gov)
• Project management tools (e.g., Microsoft Project, Asana, Trello)

ASSUMPTION: While not explicitly stated, it is assumed that candidates should have proficiency in Microsoft Office Suite and relevant regulatory affairs software and databases.

👔 Cultural Fit Considerations

Company Values:

• Integrity
• Excellence
• Customer Focus
• Inclusion
• Courage

Work Style:

• Collaborative and team-oriented
• Results-driven and focused on delivering high-quality work
• Adaptable and responsive to change

Self-Assessment Questions:

• Do you have a strong commitment to ethical and professional standards?
• Are you able to work effectively in a team environment and collaborate with cross-functional teams?
• Are you able to adapt to changing priorities and manage multiple projects simultaneously?

ASSUMPTION: Lilly values candidates who are committed to its core values and are able to work effectively in a collaborative and results-driven environment.

⚠️ Potential Challenges

• Managing multiple projects and deadlines simultaneously
• Navigating complex regulatory environments and requirements
• Building and maintaining effective relationships with regulatory agencies and other stakeholders
• Working in a fast-paced and dynamic industry

ASSUMPTION: While this role offers many opportunities for professional growth and development, it also presents unique challenges that require strong organizational skills, adaptability, and resilience.

📈 Similar Roles Comparison

• This role is similar to a Regulatory Affairs Manager or Senior Regulatory Affairs Specialist in other pharmaceutical companies
• However, this role is unique in its focus on backfilling a specific position for a one-year period
• Career progression in this role may be limited due to its temporary nature

ASSUMPTION: While this role shares similarities with other regulatory affairs positions in the pharmaceutical industry, its temporary nature and focus on backfilling a specific position make it unique.

📝 Sample Projects

• Managing the regulatory submission and approval process for a new pharmaceutical product
• Developing and implementing a regulatory compliance program for a pharmaceutical company
• Conducting regulatory landscape assessments and providing strategic recommendations to senior leadership

ASSUMPTION: These sample projects are intended to provide an example of the types of regulatory affairs projects that candidates may be expected to manage in this role.

❓ Key Questions to Ask During Interview

• What are the key priorities for this role in the first 30, 60, and 90 days?
• How does this role fit into the broader organizational structure and strategic goals of the company?
• What opportunities are there for professional development and growth within the regulatory affairs function and across the broader organization?
• How does the company support work-life balance for its employees?
• What is the company's approach to diversity, equity, and inclusion?

ASSUMPTION: These key questions are intended to help candidates better understand the role, the company, and the work environment, and to demonstrate their interest and enthusiasm for the position.

📌 Next Steps for Applicants

To apply for this position:

• Submit your application through this link
• Tailor your resume to highlight your relevant regulatory affairs experience and skills
• Prepare a cover letter that demonstrates your enthusiasm for the role and your qualifications
• Prepare examples of how you have successfully managed regulatory affairs projects or challenges in the past
• Follow up with the hiring manager one week after submitting your application to inquire about the status of your application

⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.