Sm Reg Affairs

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world&rsquos biggest brands&mdashand we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We&rsquore harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people.
Now, we&rsquore calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower.
Welcome to the relentless pursuit of better.

Inviting applications for the role of Regulatory Affairs (Senior Manager)
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 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 client.
. Improve speed to client and minimize cost to client.
. 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.

Required Education
. 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 www.genpact.com . 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 %27starter kit,%27 paying to apply, or purchasing equipment or training.

Key Skills