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Eli Lilly and Company

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4.0

based on 390 Reviews

55 Eli Lilly and Company Jobs

Manager - Global Labeling

Eli Lilly And Company

4.0

based on 390 Reviews

8-12 years

₹ 24 - 35L/yr (AmbitionBox estimate)

Bangalore / Bengaluru

1 vacancy

Manager - Global Labeling

Eli Lilly and Company

posted 21d ago

Job Role Insights

Flexible timing

Key skills for the job

Regulatory Affairs

Job Description

Purpose:
The Manager, GRA Global Labeling provides direction, leadership, and technical/process expertise to their team supporting labeling development and maintenance for Lilly products. This position provides strategic input, focuses on results, thinks critically, and emphasizes and drives cross-functional team collaboration to the achievement of goals and objectives.
The Manager/Sr Manager is responsible for appropriate resourcing, staff development and performance management, and accountable for completion of regulatory labeling activities/projects and identification/implementation of process improvement
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.

Personnel Management and Leadership

Provide leadership and direction to staff regarding departmental policies, organizational goals, objectives, performance management, regulatory knowledge, and company policies.
Hold individuals accountable for achieving goals and implementing the appropriate competency models.
Actively coach and mentor staff.
Ensure staff members receive appropriate training to perform their jobs.
Empower individuals to make logical decisions, resolve issues, and execute tasks.
Assure appropriate individual and team recognition.
Support individual technical growth and development.
Liaise with management colleagues to ensure coordinated and consistent approach to personnel management.
Strategic Planning and Implementation
Align labeling strategy with corporate directives and affiliate (US and Canada) priorities.
Actively seek out information on the needs of internal and external customers.
Collaborate with business partners and management to evaluate and support priorities.
Drive continued improvement and simplified work practices.
Participate on management teams in implementation of mission, vision, strategic intent, budget, policies, procedures, and practices.
Participate in business planning efforts.
Staffing
Successfully allocate staff and manage resources.
Provide ongoing assessment of workloads to assure balanced and maximum efficiency of individual talent and capacity.
Provide necessary resource support for key projects.
Recruit, hire, and effectively train, onboard, and integrate new staff to meet current and future needs by understanding and anticipating required future skills.
Build and maintain relationships with management in relevant areas.
Participate in supporting cross-functional activities/projects.
Facilitate Labeling Process
Remove barriers to ensure labeling activities are completed accurately, timely, and in compliance with regulatory and quality system requirements.
Provide strategic guidance to staff on labeling process questions.
Monitor regulations and the external environment as appropriate.
Provide technical, administrative, and operational support for labeling-related systems and tools.
Share regulatory knowledge with team on routine basis to establish trust and credibility.
Actively involved in Label Assessment process, responsible product selection and ensure submission of final observations on time.
Execute product transitions plan and ensure smooth transition and allocation of assets.
Organise and facilitate staff meetings and forums.
Lead/Influence/Partner
Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions.
Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
Regularly communicate within and across Global Labeling and GRA to facilitate sharing of information that allows the organization effectively support development and commercial teams.
Participate in forums that share regulatory information across GRA and other Lilly teams and business partners.
Constructively challenge teams to reach the best solutions to issues.
Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions.
Minimum Qualification Requirements:
Bachelors or master’s degree in scientific field or health sciences discipline (for example, pharmacy, chemistry, or related scientific discipline).
12+ years pharmaceutical industry-related experience and /or regulatory affairs, including 4 years in team management preferred.
Knowledge of US FDA/Health Canada and EMA procedures and practices and awareness of evolving regulatory reform initiatives.
Knowledge of drug development process and global health authority guidelines.
Demonstrated ability to work in a global matrix environment.
Demonstrated ability to communicate effectively (verbally and written), and to motivate and inspire others.
Demonstrated flexibility and strong negotiation skills.
Experience in interpreting and applying regulations.
Supervisory experience.
Other Information/Additional Preferences:
Ability to manage multiple projects/people simultaneously.
Project management experience.
Ability to influence and lead.
Effective interpersonal skills.
Willingness to work outside of normal business hours to accommodate US/EU/Asian time zones

Employment Type: Full Time, Permanent

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People are getting interviews at Eli Lilly and Company through

(based on 40 Eli Lilly and Company interviews)

Job Portal

Referral

Campus Placement

Company Website

Recruitment Consultant

38%

15%

13%

18% candidates got the interview through other sources.

High Confidence

What people at Eli Lilly and Company are saying

3.6

Rating based on 6 Manager reviews

Anonymous · Pharmaceutical & Biotechnology in Bengaluru

Likes

The salary and benefits are good. It is also a con since once you are in that salary range there are no other companies outside lilly willing to give you the expected salary.

Dislikes

They promote culture so much but in reality the upper management do not follow what they preach. There is retaliation if you raise concerns. They do not take action on survey feedback. Promotion goes to only people who talk aimlessly and not to the people who actually put in the work. The upper management will take the credit for you..Read More

Read 6 reviews