Job in Delhi, Hyderabad, Secunderabad, Mumbai City for Regulatory Affairs

Job Description

Responsibilities

• 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 labeling
• 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!

Minimum qualifications

• 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

Preferred qualifications

• Should be open to work in any shift as per the business requirement  

Contact Informations

Recruiting For : Genpact