GenpactEmployer profile
Lead Consultant Regulatory Affairs, CMC for USA market-LIF014843
Location not specified · Experience not specified
Experience- Experience not specified
Salary- Not disclosed
Location- Location not specified
- Work mode
- Not specified
- Job type
- Full-time
Apply by- Closing date not listed
- Posted
- 12 Jun 37
About this role
With a startup spirit and 115,000 + curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and 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’re 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’re 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 Lead Consultant 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 and CMC variations. US FDA post approval submissions and expertise in designing regulatory strategy and decision with respect to CMC filing.
Responsibilities
- Authoring and reviewing documents for NDA/IND and DMF annual reports.
- Handling of Post approval changes, assigning of proper category to particular change based on US FDA guidelines.
- Escalate, notify, and resolve any issues that may impact final CMC submission.
- End to end responsibility/ Life cycle management of product registered in US market.
- Responsible for maintaining internal tracker for DMF, IND/NDA Annual reports and submissions as per anniversary.
Minimum Qualifications
- B. Pharmacy / M. Pharmacy
- 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.
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 'starter kit,' paying to apply, or purchasing equipment or training.
Job
Lead Consultant
Primary Location
India-Mumbai
Schedule
Full-time
Education Level
Bachelor's / Graduation / Equivalent
Job Posting
Dec 8, 2023, 6:34:50 PM
Unposting Date
Ongoing
Master Skills List
Operations
Job Category
Full Time