Eli Lilly Regulatory Affairs jobs as Manager/Sr. Manager in Regulatory Affairs -Pharma and Chemistry candidates
Primary Responsibilities
Regulatory Planning
Plan, review and recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations & MOH processes.
Additional Responsibilities
Technically supports with Health Economic data for Drug Regulatory Agency price negotiations. Provide quality regulatory support for locally manufactured products. Provide regulatory support for locally performed clinical trials.
Minimum Qualification Requirements
- B.Pharm, M. Pharm, BSc or Master’s Degree in Chemistry or Biotechnology or related areas, or MD. Minimum 3 years of regulatory affairs experience.
- In-depth knowledge of local regulations and Regulatory Corporate policies. Have or acquire overall understanding of the local business decision-making process.
Other Information/Additional Preferences
Good knowledge of written and spoken English. Additional languages beneficial. Broad understanding of Lilly’s goals and objectives. Competent project management skills. Ability to handle multi-task activities.
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 for further assistance.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
