Genpact Walk In Interview 2022 B.Pharma/B.sc for Lead Associate, Regulatory Affairs! At Mumbai, Navi Mumbai, Mumbai (All Areas). Genpact Notification full details below..Interested and eligible candidates can attend interview on scheduled time and venue.
• Provide regulatory filing support for assigned Annual Report by providing required submission activities (planning, obtaining required data (CMC/ancillary documents), coordination, reviewing, and release) in accordance with regulatory requirements and timelines.
• Respond to health authority questions or local subsidiary requests for additional information to support the Annual Reports.
• Administrative Content (Module 1) preparation for Annual Reports-US market.
• To handle Regulatory document management systems: ORION -COGNOS, VEEVA, REDS, SPARS, etc.
• Coordinate with clients in tracking and status update of project plans.
• Ensure timely submission of Annual Reports to the agency.
• Coordinate team review, electronic content publishing, and release of the Annual Report submission content.
Qualifications we seek in you!
• Bachelors or masters degree (or another advanced degree) preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline requirement
• Bachelors degree preferably in Pharmacy, Biological Science, Chemistry, Nursing, or related discipline required with related experience in the pharmaceutical industry. Alternatively, a masters or another advanced degree with relevant experience in the pharmaceutical industry
• Excellent organizational skills and a proven ability to multi-task
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance.) Demonstrated proficiency in RCAM or advanced document control system. Superior attentiveness to details
• Ability to generate innovative solutions to problems and effectively work with and communicate with key stakeholders
• Flexibility in responding to changing priorities or dealing with unexpected events
• Capability to handle multiple priorities and balance work to achieve business goals
• Effective leadership, communication and interpersonal skills.
• Ability to prioritize tasks to meet deadlines and collaborate with a team when help is needed
• Ability to identify problems and work with the team to formulate a potential course of action
• Willing to work for US Shift
Preferred Qualifications / Skills
• Demonstrated understanding of regulatory affairs and pharmaceutical registrations
• Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key partners
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
• Capability to prioritize multiple priorities and balance work to achieve business goals
• Demonstrated effective leadership, communication, and interpersonal skills
Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and industry expertise to deliver disruptive business outcomes – an approach we call Lean DigitalSM.