Senior Manager - Regulatory Affairs
Senior Manager - Regulatory Affairs
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Job Description
Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125000 people across 30 countries are driven by our innate curiosity entrepreneurial agility and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people we serve and transform leading enterprises including the Fortune Global 500 with our deep business and industry knowledge digital operations services and expertise in data technology and AI.
Inviting applications for the role of Senior Manager- Regulatory Affairs!
In this role you will be expected to work on deadlines in a fairly high-pressure business
environment while being a good great teammate.
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
Preferred qualifications
Should be open to work in any shift as per the business requirement
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race color religion or belief sex age national origin citizenship status marital status military/veteran status genetic information sexual orientation gender identity physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion respect and integrity customer focus and innovation. For more information visit . Follow us on Twitter Facebook LinkedIn and YouTube.
Furthermore please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a starter kit paying to apply or purchasing equipment or training.
Required Experience:
Senior Manager
Employment Type
Full-Time
