Regulatory Associate Manager

Site Name: Bengaluru Luxor North Tower Posted Date: Aug 9 2022 Is there any greater challenge than getting ahead of disease? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Job Purpose The Job holder works within the development delivery team manager to ensure that appropriate content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role. Key Responsibilities Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. A good understanding of Clinical Trial Directive, DIA TMF Reference Model and CTA/IND submission requirements for multiple countries/submission types Responsible for: coordination, development, refinement of the CTA/IND lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures. Accountable to the CTA Team Manager for overall work plans, accountable to individual GRLs/TGs for study submission planning & delivery status. Accountability for agreed tasks and projects. Ensure independent communication, with a range of internal GSK staff, in supporting achievement of the assigned goals. Ensure quality of both own and submission team’s work, delivering to agreed timeframes, including compliance with GSK systems and record keeping. Provide input to internal processes and written standards. To work flexibly to meet constant shifting priorities and timelines May provide support to other activities within the CTA/IND and/or Content Delivery Team. Knowledge/ Education / Previous Experience Required:- 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 Specialization - Chemistry, pharmacy or other related science or technical bachelors degree. B. Job-Related Experience Job-Related Experience required - 5 years of relevant experience C. Other Job-Related Skills/Background :- Knowledge of practical implementation of the European Clinical Trial Directive. Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. A good understanding of Clinical Trial Directive and CTA/IND submission requirements for multiple countries/submission types Excellent organisational 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 Ability to build effective working relationships and work in a matrix environment effectively Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams. Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome. Ability to think flexibly to meet constantly shifting priorities and timelines. At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. *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. 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. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKilne (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing [email protected], so that we can confirm to you if the job is genuine.