Manger Regulatory Affairs Labelling For Usa Market

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Inviting applications for the role of Manger Regulatory Affairs, Labelling for USA market
In this role Candidate should have experience in labelling regulation and requirements for US market including good knowledge of CCDS, Non-CCDS and Annual reportable labelling changes. Management process for Product website labeling changes, Editorial labeling changes, Labeling content development (PM and packaging components), including: CCDS updates and associated label negotiation and HC mandated label updates. Also, the candidate should have hands-on experience of labelling tools.

Responsibilities

1. Change management process of CCDS, Non-CCDS and Annual reportable labelling changes.
2. Analysis of competitor information (e.g., labels, approval packages) for regulatory policy projects and/or labelling projects
3. Escalate, notify, and resolve any issues that may impact final labelling submission.
4. End to end responsibility of Labelling For product registered in the US market.
5. Responsible for maintaining internal tracker for CCDS, Non-CCDS and Annual reportable labelling changes and submissions.

Qualifications we seek in you!
Minimum Qualifications
B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.

Preferred Qualifications/ Skills
. Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
. Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
. Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables.
. Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.
. Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
. Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.
. Depending on experience level, mentor newly hired staff or lead a team of junior staff.
. Flexibility in responding to changing priorities or dealing with unexpected events.
. Capability to handle multiple priorities and balance work to achieve business goals.

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