Job title: Principal Reg Specialist l/ll -Submission Coordination
Company: GlaxoSmithKline Pte Ltd
Job description: Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Jan 18 2022 Job Purpose: The Job holder works with the Content Delivery Project Lead or GRL/ Regional Rep (TG)/LOC (or equivalent) or Functional teams or C&EP equivalent to ensure
Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Jan 18 2022 Job Purpose: The Job holder works with the Content Delivery Project Lead or GRL/ Regional Rep (TG)/LOC (or equivalent) or Functional teams or C&EP equivalent to ensure that appropriate content for specific submissions supporting R&D projects and Commercial is developed and delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role. The job holder will serve as a mentor and/or trainer for new team members and will also be a Subject Matter Expert for specific areas, Regulatory requirements/ guidelines & GSK Process/Ways of working for consultation within the team/ department as well as externally outside the department. Key Responsibilities: Accountable to Project Lead or GRL/ Regional Rep/ C&EP TG / /LOC or equivalent with input from Functional teams (e.g. CMC/Clinical/nonclinical) for delivery of assigned complex submissions to agreed timeframes and appropriate content, independently and confidently for EU and Rest of the world (ROW) markets. Ensure alignment and clear understanding of Regulatory Requirement/Legislation/ Guideline for EU and ROW markets. Ensures quality of both own and submission team’s, work and compliance with regulatory guidelines and process as they apply to the role. Deliver complex submission packages Right first time to agreed schedule and technical specification & share the knowledge with the team. Possess in depth knowledge of GSK processes, ways of working and current EU and ROW market Guidelines to be the Subject matter expert and provide training, consultation and solutions within the team/ department as well as externally outside the department Independently manages multiple project assignments with different complexity Regular communication with line manager or technical lead/Functional teams to help identify any issues with business impact and ability to offer potential solutions. Identifies risks associated with submission data and submission packages Works with staff from other functions/Departments and should be capable of working to senior levels in process development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues. Identify, discuss & implement potential process improvements/simplifications in the current processes, being subject matter expert in processes, to enhance team efficiency while maintaining quality. Also should be capable of building new process as and when required. May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities. May be responsible for the maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions etc Site Registrations/Site Renewals, Tenders, Variations etc. Resolve issues with stakeholders with appropriate sense of urgency and with no input or minimal input from manager May represent GSK externally (e.g. Audits, Conferences, External Forums). Basic Qualifications: Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment Preferred Qualifications: Masters degree or higher in biological or healthcare science Job-Related Experience: More than 7 years of Global/EU/ROW Regulatory submission experience – Knowledge of regulatory agency guidelines Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. Excellent Leadership & organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines Excellent written and verbal communication skills and ability to present information in a clear and concise manner Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience Ability to build effective working relationships/ Stakeholder management and work in a global matrix environment effectively Ability to think flexibly in order to meet constantly shifting priorities and timelines. Training/mentoring/Coaching Skills Strong Negotiation/persuasive and Project management/Co-ordination skills. Should be compliant of GSK values and expectations. Other Job-Related Skills: Extensive Knowledge of drug development and manufacturing and supply processes. Extensive Knowledge of worldwide regulatory requirements. Ability for overseeing and prioritizing multiple activities across one or more sites for multiple customers Ability to define and implement new processes and quality initiatives with an awareness of relevant controls and impacts. Highly developed interpersonal, and presentation with established internal and external networks. Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager. Service orientation, customer-focused *LI-GSK Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. 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Location: Bangalore, Karnataka
Job date: Thu, 20 Jan 2022 23:42:05 GMT
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