- 8-10 years of core global labeling experience
- Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels.
- Demonstrates knowledge and understanding of company Core Data Sheets (CDS) and the dynamics of Labelling Team purpose and objectives.
- Demonstrates ability to understand how updating one section of a label may impact another and to propose recommendations to the Labelling Team.
- Clear and effective written and verbal communication skills.
- Ability to liaise with stakeholders using effective means of communication
- Demonstrates ability to influence and negotiate where necessary, across a highly matrixed team.
- Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
- Ability to interact effectively with all levels/roles of project team members.
- Ability to manage time effectively across all projects,



and work on many tasks in parallel.
- Takes ownership and accountability for assigned projects.
- Proven ability to effectively lead project team members in order to resolve issues.
- Consistent ability to foster solid matrix team working relationships. Proven track record of facilitating groups of individuals to work together on creating solutions.
- Proven ability to make sound decisions.
- Interfaces directly with senior management as appropriate on prescribing information content and requirements.
- Independently seeks to resolve problems in a proactive manner.
- Proven understanding of the dynamics and purpose of the companys CDS; experience in reviewing and understanding of implications of the CDS.
- Possesses advanced knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.
- Proven ability to successfully understand regulatory implications of product s

📌 Global Labelling Lead (Pune)
🏢 Indegene
📍 Pune