Manager, Regulatory Affairs World Courier

3.0 - 7.0 years

5 - 9 Lacs

noida

Work from Office

Job Details Develop and maintain strong client relationships and actively explore opportunities for increased service support to Line Manager. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communication with clients and Health Authorities. Support with scientific advice procedures and representation of clients with health authorities. Responsible for the planning and execution of client projects in accordance with KPIs. Coordination of project teams with colleagues and qualified external partners. General guidance (consultancy) of colleagues and clients regarding CMC Services. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. Present seminars and lectures for colleagues, clients and professional audiences. Active contribution and distribution of department relevant expertise. Support with VDC strategy implementation and optimization. Comply with, maintain and contribute to optimizing internal processes. Support with VDC led commercial, marketing and business development activities including proposal input. Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries. In agreement with Head of VDC REG providing on-site regulatory support to GCS clients. The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG. Handling of M3 databases Compilation/handling of wToCs for renewals/variations Drafting of eAFs and country information letters for dispatch packages Communication with local affiliates regarding local requirements Change assessments according to EU variation guideline CMC background preferred, IT affinity, very detail oriented, excellent communication skills Maintain knowledge and understanding of SOPs and current regulatory guidelines as applicable.

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Senior Engineer Larsen & Toubro (L&T)

4.0 - 9.0 years

8 - 9 Lacs

nazira

Work from Office

This position will provide project management leadership and technical engineering support to land equipment and system projects. Spends the majority of time achieving organisational objectives through the coordinated achievements of site team. Manages experienced professionals who exercise latitude and independence in assignments.Establishes departmental goals and objectives, functions with autonomy. Manages the accountability and stewardship of human, financial, and often physical resources in compliance with departmental and company wide goals and objectives. Ensures subordinate supervisors and professionals adhere to defined internal controls with a focus on policy and strategy implementation. Manages systems and procedures to protect departmental assets and requires practical knowledge in leading and managing the execution of processes, projects and tactics within Through Life Support function especially in Maintenance Transfer of Technology Aspects. Knowledge, Skills, and Abilities: Minimum of 4 years of field service management or project management experience. Must have strong technical ability on installation and STW of electromechanical equipment. Individual should be able to interact and develop relationships with customers and business partners. Excellent verbal and written communication skills Fluent in use of MS-Office products, especially Word and Excel Dynamic and passionate with a strong teamwork mentality Ability to manage internal and external clients. Ability to organise and manage system installation and maintenance to create and maintain effective safety and operational processes. Skilled in the application of Project Management Principles. Capable of managing and mentoring subordinates and managing multiple projects. Key Responsibilities Interface regularly with internal and external clients providing project information and status updates including timeline, budgets and deliverables. Manage operations and scheduling for the site activities and associated resources. Supervise installation and commissioning of equipment in customer facility.Manage and document applicable standard operating procedures (SOP) and safety processes. Ability to negotiate with business partners and influence others to build consensus and achieve customer objectives in time bound manner.

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