Site Name: Bengaluru Luxor North Tower Posted Date: Feb 12 2025 Basic Qualifications: Years of experience 10 - 15 Years. Education - Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment Location - Bangalore. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc) May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines. May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development) May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets May be required to lead or participate to process improvement initiatives May be required to take on additional Project Management responsibilities if identified as Single Point of Contact (SPOC) for the GRL Preferred Qualifications: If you have the following characteristics, it would be a plus: Excellent written and verbal communication skills and ability to present information in a clear and concise manner Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines. Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management tools Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status. Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management, etc. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness Inclusion & Diversity at GSK: At GSK, we are dedicated to fostering an inclusive and diverse work environment. We believe that diversity in our workforce drives innovation and growth, and we are committed to providing equal opportunities for all employees and applicants. We strive to create an atmosphere where all individual’s unique perspectives and experiences are valued and respected. All qualified applicants will receive equal consideration for employment without regard to their sex or gender, caste, pregnancy, gender identity/expression, physical and/or mental disability, or any other protected characteristic as per applicable law. As an employer committed to Diversity and Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs. *This is a job description to aide in the job posting, but does not include all job evaluation details. Why GSK? Uniting science, technology and talent to get ahead of disease together. 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). 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. 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 GlaxoSmithKline (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 askus@gsk.com, so that we can confirm to you if the job is genuine.