Genpact Limited, a global leader in business process and technology management services, leverages the power of smarter processes, smarter analytics and smarter technology to help its clients drive intelligence across the enterprise. Genpact’s Smart Enterprise Processes (SEP) framework, its unique science of process combined with deep domain expertise in multiple industry verticals, leads to superior business outcomes.
Post : Lead Associate - Regulatory Affairs-LIF012815
Job Description
• The Annual Report Submission Planner is responsible to 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 to 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.
• Coordination with clients in tracking and status update of project plans.
• Ensure a timely submission of Annual Reports to the agency.
• Coordination team review, electronic content publishing, and release of the Annual Report submission content.
• Willing to work for US Shift
Candidate Profile
• Bachelor’s or master’s degree (or other advanced degree) preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline requirement.
• Bachelor’s degree preferably in Pharmacy, Biological Science, Chemistry, Nursing, or related discipline required with at least 4 years of related experience in the pharmaceutical industry. Alternatively, a master’s or other advanced degree with relevant experience in 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 to 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 team to formulate a potential course of action.
Preferred 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.
Additional Information
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Mumbai, Maharashtra
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Regulatory Affair
End Date : 10th August, 2023
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