Senior Associate, Regulatory Affiliate - Backfill (1 Year)

📌 Core Information

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

🔹 Company: Eli Lilly and Company

🔹 Location: Seoul, South Korea

🔹 Job Type: Full-Time

🔹 Category: Pharmaceuticals

🔹 Date Posted: July 21, 2025

🔹 Experience Level: Entry-Level (0-2 years)

🔹 Remote Status: On-site

🚀 Job Overview

Key aspects of this role include:

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

ASSUMPTION: This role requires a balance of technical expertise and strong interpersonal skills to navigate regulatory environments and collaborate effectively with various teams.

📋 Key Responsibilities

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

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

✅ 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

✅ Facilitate interactions with regulatory bodies on a regular basis

✅ Ensure that all products comply with local regulations and quality system requirements

✅ 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

✅ Build and maintain relationships with key regulatory officials (External Influence)

✅ Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives

ASSUMPTION: The role involves a mix of strategic planning, operational execution, and stakeholder management, requiring strong organizational skills and attention to detail.

🎯 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

Required Skills:

• Knowledge of local regulations and regulatory procedures
• Strong communication and analytical skills
• 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
• Good capability to establish positive networking both internally and externally
• Strong knowledge of quality systems

ASSUMPTION: While the role requires specific technical skills, the ability to work effectively in a team and adapt to changing circumstances is equally important.

💰 Compensation & Benefits

Salary Range: The salary range for this role in Seoul, South Korea, is typically between ₩50,000,000 and ₩65,000,000 per year (approximately USD $41,000 - $53,000) for entry-level positions in the pharmaceutical industry. This estimate is based on industry standards and may vary depending on the candidate's qualifications and experience.

Benefits:

• Health, dental, and vision insurance
• Retirement savings plan with company match
• Paid time off (vacation, sick, and holidays)
• Employee assistance program
• Tuition assistance and professional development opportunities

Working Hours: Full-time position with standard working hours Monday through Friday, 9:00 AM to 6:00 PM. Overtime may be required as needed.

ASSUMPTION: The salary range provided is an estimate based on industry standards and may vary depending on the candidate's qualifications and experience. Benefits are subject to change and may vary by location.

📌 Applicant Insights

🔍 Company Context

Industry: Eli Lilly and Company operates in the pharmaceutical manufacturing industry, developing and marketing medicines to improve the lives of patients worldwide.

Company Size: Eli Lilly and Company is a large organization with over 10,000 employees globally. This size offers opportunities for career growth and exposure to diverse projects and teams.

Founded: Eli Lilly and Company was founded in 1876 by Colonel Eli Lilly. The company has a rich history of innovation and commitment to improving patient lives.

Company Description:

• Eli Lilly and Company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those who need them.
• The company focuses on areas of highest unmet medical need, including neuroscience, diabetes, cancer, and autoimmune diseases.
• Eli Lilly and Company is committed to improving the lives of patients and making a positive impact on communities around the world.

Company Specialties:

• Pharmaceutical Development
• Pharmaceuticals
• Biotech and Biopharmaceuticals

Company Website: www.lilly.com

ASSUMPTION: Eli Lilly and Company is a well-established and respected organization in the pharmaceutical industry, offering opportunities for professional growth and development.

📊 Role Analysis

Career Level: This role is an entry-level position, offering an opportunity to gain experience in regulatory affairs and grow within the organization.

Reporting Structure: The Senior Associate, Regulatory Affiliate reports directly to the Regulatory Affairs Manager and works closely with cross-functional teams, including marketing, sales, and medical affairs.

Work Arrangement: This is an on-site position based in Seoul, South Korea. The role may require occasional travel to other Lilly offices or regulatory agency meetings.

Growth Opportunities:

• Progression to a more senior regulatory affairs role within the affiliate or global organization
• Expansion of responsibilities to include additional products or therapeutic areas
• Opportunities to work on special projects or initiatives to gain exposure to different aspects of the business

ASSUMPTION: This role offers a strong foundation for a career in regulatory affairs, with opportunities for growth and development within the organization.

🌍 Location & Work Environment

Office Type: Eli Lilly and Company's Seoul office is a modern, collaborative workspace designed to foster innovation and productivity.

Office Location(s): Lilly Corporate Center, Indianapolis, Indiana 46285, US (global headquarters); Seoul, South Korea (affiliate office)

Geographic Context:

• Seoul, South Korea, is a vibrant, multicultural city with a rich history and modern amenities
• The city offers a high quality of life, with excellent education, healthcare, and entertainment options
• Seoul is well-connected by public transportation, making it easy to commute to work

Work Schedule: The work schedule for this role is Monday through Friday, 9:00 AM to 6:00 PM, with occasional overtime as needed. The role may require flexibility to accommodate regulatory agency meeting schedules or project deadlines.

ASSUMPTION: The work environment at Eli Lilly and Company's Seoul office is collaborative and supportive, with a focus on innovation and patient-centered care.

💼 Interview & Application Insights

Typical Process:

• Online application submission
• Phone or video screening with the hiring manager
• In-person or virtual interview with the hiring manager and other team members
• Final interview with the Regulatory Affairs Director or another senior leader

Key Assessment Areas:

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

Application Tips:

• Tailor your resume and cover letter to highlight relevant regulatory affairs experience and skills
• Prepare for behavioral interview questions that focus on your problem-solving, communication, and teamwork skills
• Research Eli Lilly and Company and the regulatory affairs function to demonstrate your enthusiasm for the role and understanding of the industry

ATS Keywords: Regulatory Affairs, Pharmaceuticals, Compliance, Project Management, Communication, Problem-Solving, Negotiation, Teamwork, Quality Systems, Local Regulations

ASSUMPTION: The interview process for this role is designed to assess the candidate's technical skills, cultural fit, and potential for growth within the organization.

🛠️ Tools & Technologies

• Microsoft Office Suite (Word, Excel, PowerPoint)
• Regulatory information management systems (e.g., Veeva Vault, ArisGlobal's LifeSphere Regulatory)
• Project management tools (e.g., Microsoft Project, Asana, Trello)
• Communication and collaboration platforms (e.g., Microsoft Teams, Slack)

ASSUMPTION: The tools and technologies required for this role are standard for the pharmaceutical industry and can be learned or improved upon with experience.

👔 Cultural Fit Considerations

Company Values:

• Integrity
• Excellent
• Patient-centered
• Innovative
• Collaborative

Work Style:

• Collaborative and team-oriented
• Focused on delivering high-quality results
• Adaptable and responsive to change
• Committed to continuous learning and improvement

Self-Assessment Questions:

• Do you have a strong commitment to ethical behavior and integrity?
• Are you able to work effectively in a team and collaborate with diverse stakeholders?
• Are you comfortable working in a dynamic and changing environment?
• Do you have a passion for learning and continuous improvement?

ASSUMPTION: Eli Lilly and Company values a diverse and inclusive work environment, and candidates who demonstrate a strong cultural fit and commitment to the company's values are more likely to succeed in the role.

⚠️ Potential Challenges

• Navigating complex regulatory environments and maintaining compliance with local regulations
• Balancing multiple priorities and meeting tight deadlines
• Adapting to changes in regulations or project scope
• Working effectively with cross-functional teams and stakeholders

ASSUMPTION: These challenges can be overcome with strong technical skills, effective communication, and a commitment to continuous learning and improvement.

📈 Similar Roles Comparison

• Compared to other regulatory affairs roles, this position offers a unique opportunity to gain experience in a specific therapeutic area or product portfolio
• Regulatory affairs roles in the pharmaceutical industry often require similar skills and knowledge, but the specific focus and responsibilities may vary
• This role offers a clear career path for progression within the regulatory affairs function or the broader organization

ASSUMPTION: While regulatory affairs roles share many similarities, the specific focus and opportunities for growth may vary depending on the company and the role.

📝 Sample Projects

• Managing the regulatory submission for a new product launch in the South Korean market
• Collaborating with cross-functional teams to develop and implement a regulatory strategy for a line extension or new indication
• Conducting a regulatory landscape assessment to identify opportunities and risks in the South Korean market

ASSUMPTION: These sample projects illustrate the range of responsibilities and opportunities available in this role, from strategic planning to operational execution.

❓ Key Questions to Ask During Interview

• Can you describe the regulatory landscape for the products in this affiliate and the key priorities for the role in the first year?
• How does this role collaborate with other functions, such as marketing, sales, and medical affairs, to achieve affiliate objectives?
• What opportunities are there for professional development and growth within the regulatory affairs function or the broader organization?
• How does Eli Lilly and Company support work-life balance for its employees?
• What are the key challenges facing the regulatory affairs function in the South Korean market, and how can this role contribute to addressing them?

ASSUMPTION: Asking thoughtful questions during the interview process demonstrates your interest in the role and commitment to understanding the organization and its priorities.

📌 Next Steps for Applicants

To apply for this position:

• Submit your application through the following link: https://lilly.wd5.myworkdayjobs.com/LLY/job/Korea-Seoul/Senior-Associate--Regulatory-Affiliate---Backfill--1-Year-_R-89464-1
• Tailor your resume and cover letter to highlight your relevant regulatory affairs experience and skills
• Prepare for behavioral interview questions that focus on your problem-solving, communication, and teamwork skills
• Research Eli Lilly and Company and the regulatory affairs function to demonstrate your enthusiasm for the role and understanding of the industry
• Follow up with the hiring manager one week after submitting your application to express your continued interest in the role

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