Labelling- Senior Manager-English-Remote UK

Basic Information
Ref # LIF009605
Location London UK - Office
Date Published: Monday, October 31, 2022
Band 4D
Points 600
Description
With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently and are bold enough to reinvent it. Come, transform with us.

We are Genpact. Transformation happens here. Come, be a part of our exciting journey!

Transformation happens here. Come, be a part of our exciting journey!

Inviting applications for the role of – Labelling- Senior Manager-English-Remote UK

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 labelin
• 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 
• Should be open to work in any shift as per the business requirement
Preferred Qualifications
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
What we offer?
• Attractive salary;
• Stable job offers - employment contract
• Work in a multicultural and diverse environment with employees from over 30 countries
• Genpact supports langauge courses, professional tranings and great career development opportunities
• Free access to our award-winning learning platform

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