Senior Manager - Regulatory Affairs

Genpact

5 - 10 years

Hyderabad

Posted: 06/06/2025

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 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

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

About Company

Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.