Details of the Organization
At Genpact, we're not just a company; we're a community of over 115,000 individuals driven by curiosity and courage. With our startup mindset, we dive deep into the world's leading brands, infusing fun into every challenge we tackle. Our passion lies in digital innovation, where dreams meet reality, and where we continuously redefine the norms of business operations. By blending technology and human ingenuity, we're committed to making a real impact that extends far beyond profit margins. We're on the lookout for individuals who share our appetite for discovery and growth, those who aren't afraid to experiment and push boundaries. Join us in our journey to create a better world, and in return, we'll empower you to sharpen your intellect and shape your future.
Details of the Job/Internship
Genpact is seeking applications for Lead Consultant Regulatory Affairs, CMC for the USA market. Ideal candidates should possess regulatory affairs experience, expertise in lifecycle document management (LCM), and a strong understanding of ICH and FDA guidelines. Proficiency in DMF, NDA/IND Annual report, CMC variations, and US FDA post-approval submissions is required. The role entails designing regulatory strategies and making decisions related to CMC filings. If you meet these qualifications, we encourage you to apply.
Role and 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.
Qualifications we seek in you!
Eligibility
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.
Salary/Stipend
The salary will be discussed with the candidate itself.
Type of Opportunity
Fulltime
Country
India
State
Maharashtra
City
Mumbai
Address
Mumbai, Maharashtra