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Lead Associate - Regulatory Affairs

2.00 to 5.00 Years   Mumbai City   15 Feb, 2022
Genpact India Pvt Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other SoftwareSales / BD
EmploymentTypeFull-time

Job Description

    Lead Associate, Regulatory Affairs You will be responsible for managing all the activities involved in planning, and dispatching US Annual Reports. Responsibilities: 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 Qualifications we seek in you 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 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.,

Keyskills :
customer relationsreportingslaaccountsbasishandle multiple prioritiescontinuous improvement facilitationannual reportscustomer focus

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