Genpact - Manager/Senior Manager - Regulatory Affairs - Labeling

- 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 Manager/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 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

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 www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.