- Monitor and develop continuous improvement proposals on the processes
- Maintain a staff of adequately skilled resources to meet deliverables
- Communicate issues and resolve them in an appropriate time frame
- Ensure adherence to agreed-to work practices
- Meet established submission timelines and quality standard.
- Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labelling
- Ensure collection of metrics
- Improve speed to minimize the cost
- Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions
Qualifications we seek in you!
- Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives
- Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts
- 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. Proficient in speaking publicly to senior management when required
- Must be able to construct a Company Response (MAH response) for health authority questions
- Masters in Life Sciences
- Understanding of key regulatory and Labeling principles and SOPs
- Should be open to work in any shift as per the business requirement
6-9 years' experience in Regulatory affairs
Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields.
Marketing authorization experience.
Proven Project Management experience