Job title: Regulatory Specialist CTA/IND Development Delivery
Job description: Job Description : Site Name: Bengaluru Luxor North Tower, India – Maharashtra – Worli Mumbai Posted Date: Jul 21 2022 Key Responsibilities (10 bullet points maximum) Describe the key deliverables to be achieved by the post holder and the ongoing res
Job Description : Site Name: Bengaluru Luxor North Tower, India – Maharashtra – Worli Mumbai Posted Date: Jul 21 2022 Key Responsibilities (10 bullet points maximum) Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role Coordination of CTA/IND submissions, to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures Accountable to the functional CTA/IND Team Lead for overall work plans and to Global Regulatory Leads or Regional Representatives for definition of requirements within an agreed project. Accountability for agreed tasks and projects. Ensure independent communication, with a range of internal GSK staff, in support achievement of the assigned goals. Ensure compliance with GSK CTA/IND process through timely action and completion of records in internal GSK systems Ensure quality of own work to agreed timeframes, including compliance with GSK systems and record keeping. Knowledge/ Education / Previous Experience Required. A. Educational Background List any academic or practical education that must be obtained to be qualified to perform this role. 1. Minimum Level of Education. Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment Area of Specialisation. Chemistry, pharmacy or other related science or regulatory affairs Why is this Level of Education Required Working in complex environment within a scientific organization B. Job-Related Experience Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role. Minimum Level of Job-Related Experience required 2-3 years of relevant experience Why is this Level of Experience Required Role requires a general understanding of CTA/IND submission requirements for multiple countries/ submission types and an ability to work in a matrix environment. C. Other Job-Related Skills/Background List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job. Knowledge of practical implementation of the European Clinical Trial Directive. Knowledge and experience of filing artefacts per the DIA Trial Master File Reference Model. Knowledge of clinical trial application process and review for countries outside Europe would be an advantage. Understanding of the use and importance of internal tracking to ensure compliance with reporting and other requirements for each study protocol. Pays attention to detail is aware of the importance of accuracy and the need for compliance with internal and external policy and regulations. Sound interpersonal and communication skills to ensure sound level of engagement of others An ability to manage multiple tasks in parallel and organize time and actions within submission or project timeframes Able to work effectively in, and promote, sound team working across organizational boundaries Works co-operatively with others, individually or in teams, in order to achieve project or product goals. Takes time to reflect on own performance and learn from experience to improve overall performance and input to process improvements to benefit other projects. Ability to work in multiple IT systems (filing, tracking & repositories) 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. 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Location: Bangalore, Karnataka
Job date: Sat, 23 Jul 2022 22:58:01 GMT
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