Manager Regulatory Affairs, CMC For USA market.

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Inviting applications for the role of Manager Regulatory Affairs, CMC for USA market.
In this role Candidate should have experience in regulatory affairs while essential exposure to the lifecycle document management (LCM) and also need to have good knowledge of ICH guideline and FDA guideline for US market. In depth working knowledge of DMF, NDA/IND Annual report, Safety Reports and CMC variations. US FDA post approval submissions and expertise in designing regulatory strategy and decision with respect to CMC filing.

Responsibilities

1. Authoring and reviewing of documents for NDA/IND and DMF annual report and Safety Reports (PABER, PADER and DSUR).
2. Handling of Post approval changes, assigning of proper category to particular change based on US FDA guidelines.
3. Escalate, notify and resolve any issues that may impact final CMC submission.
4. End to end responsibility/ Life cycle management of product registered in US market.
5. Responsible for maintaining internal tracker for DMF, IND/NDA Annual reports, Safety Reports (PABER, PADER and DSUR) and submissions as per anniversary.

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

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. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.
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