Regulatory Specialist-II -CTA/IND Development delivery

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.<br>Find out more:<br><a href="https://www.gsk.com/en-gb/innovation/">Our approach to R&D</a> Position Summary You will support preparation and delivery of Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions. You will work closely with global regulatory, clinical, CMC, quality and external partners. We value clear communicators who are organised, rigorous and collaborative. This role offers hands-on submission experience, growth in regulatory systems, and the chance to influence work that advances patient-focused science and innovation. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Compile, format and deliver CTA/IND dossiers according to agreed strategy and timelines. - Coordinate document collection from clinical, CMC, quality and external vendors and track completeness. - Perform quality checks on dossier content to ensure compliance with regulatory expectations. - Maintain and update submission records in regulatory systems and carry out routine data checks. - Support responses to health authority questions and follow up on information requests. - Contribute to process improvements, system testing and creation of clear team guidance. Responsibilities - Deliver assigned submission components on time and to defined quality standards. - Identify and escalate risks or missing information that could impact delivery. - Communicate status updates and coordinate with cross-functional project teams. - Prepare regulatory correspondence and support preparation of supporting documentation. - Provide basic user support for submission tools and participate in user acceptance testing. - Help create clear work instructions and share knowledge across the team. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals - Bachelor’s degree in life sciences, pharmacy, chemistry or a related field. - 2 to 5 years of regulatory affairs, submissions or regulatory operations experience. - Practical experience preparing clinical trial or early-phase regulatory dossiers. - Working knowledge of regulatory requirements for CTA/IND submissions. - Experience with document management or submission systems and MS Office tools. - Good written and verbal English communication and ability to work with global teams. Preferred Qualification If you have the following characteristics, it would be a plus - Experience with electronic submission formats or systems such as Veeva Vault. - Familiarity with eCTD publishing or non-eCTD dossier structures. - Understanding of CMC and clinical documentation requirements for early-phase dossiers. - Experience in regulatory information management, data quality checks or tracking. - Prior experience in a regulated environment such as clinical research or manufacturing. - Postgraduate degree or professional certification in regulatory affairs or related field. Working Model This role is on-site in India with occasional hybrid flexibility subject to business needs. You will work with colleagues across time zones and with global partners. We encourage you to apply If this role fits your skills and career goals, we want to hear from you. Tell us what you have delivered and what you want to learn next. If you need adjustments during recruitment, please tell us so we can support you. Apply now to help move important regulatory work forward.<p></p><p><b>Why GSK?</b></p><p><b>Uniting science, technology and talent to get ahead of disease together.</b></p><p></p><p>GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.</p><p></p><p>People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.</p><p></p><p><b>Inclusion at GSK:</b></p><p>As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.</p><p></p><p>Please contact our Recruitment Team at <a target="_blank" href="http://IN.recruitment-adjustments&#64;gsk.com"><span style="color:#0000ff"><u>IN.recruitment-adjustments&#64;gsk.com</u></span></a> to discuss your needs.</p><p></p><p><b>Important notice to Employment businesses/ Agencies</b></p><p>GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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