Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Nov 28 2023
Job Purpose :

• The Regulatory Submission Assembly \xe2\x80\x93 Level 1 role is to co-ordinate between multiple stakeholders/LOC, to obtain regulatory submission documents for preparation of quality dossier in agreed timeline and submissions to respective agencies with high quality.

Supports Global Regulatory by producing appropriate components for global regulatory dossiers with minimal input from line manager. Key Responsibilities :

• Drive the submission and delivery process with the Global Publishing team to ensure timely dispatch and archival of submissions as per the agreed timelines.
• Delivery of submission packages to agreed schedule and technical specification
• Advise and assist authors with the preparation of submission content and use of GSK document management systems and procedures
• Works across the functions and can work with Stakeholders in development functions in provision of advice interpretation of relevant guidance\xe2\x80\x99s, researching topics and resolving issues.

Understanding of regulations, guidelines and developing procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications . Job-Related Experience :

• 0-6 years of experience in Regulatory Affairs or related responsibilities
• Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to build effective working relationships and work in a matrix environment effectively.
• Excellent computer knowledge (e.g. MS Word, MS Excel, Adobe PDF, SharePoint, Internet Explorer etc.) and preferably experience with the use of complex IT tools in a large organization
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.

. Other Job-Related Skills/Background

• Can communicate effectively in English.
• Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way.
• Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
• Highly developed interpersonal, presentation and communication skills with established internal and external networks.

Ability to work carefully/independently under time constraints. Why Us? GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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 \xe2\x80\x9cgsk.com\xe2\x80\x9d, 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.