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Job Description

With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world&rsquos biggest brands&mdashand we have fun doing it. Now, we&rsquore calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.

Are you the one we are looking for

We are inviting applications for the role of 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.

Solid understanding of key regulatory and Labeling principles and SOPs

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


§Monitor and develop continuous improvement proposals on the processes.

§Maintain a staff of adequately skilled resources to meet deliverables.

§Communicate issues and resolve in an appropriate time frame.

§Ensure adherence to agreed-to work practices.

§Meet established submission timelines and quality standards.

§Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labeling.

§Ensure collection of metrics required by Sanofi.

§Improve speed to Sanofi and minimize cost to Sanofi

Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions

§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

Qualifications we seek in you!

Minimum qualifications:

. Masters in Life Sciences

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

Job Source:

Genpact is an American professional services firm legally domiciled in Bermuda with its headquarters in New York City, New York. The company currently employs more than 100,000 people and provides services to clients in over 30 countries worldwide

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