Job Description

Site Name: India - Maharashtra - Worli Mumbai Posted Date: Feb 16 2023 Ready to help shape the future of healthcare 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. 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- Assist the Regulatory Affairs Manager in fulfilling regulatory responsibilities for activities related to registration of new drugs and lifecycle management of existing products for Pharma, Biopharm, Cosmetics and Vaccines for India. Key Responsibilities- 1. Compilation and submission of Quality Regulatory Dossiers for following categories of applications for Pharma, Biopharm, Cosmetics and Vaccines products: . New Products (NDA/Marketing Authorization) and Line Extensions/Additional Indications . Clinical Trial Applications (local/global studies) . Registration of Manufacturing Sites & Products, Import Licenses . Maintenance Applications/Life cycle management: Renewals of Registration Certificates/Import Licenses Technical Variations (CMC) Clinical Trial Protocol Amendments/ Study updates and other compliance activities Post Approval Commitments (PACs) PSURs RMPs . Prescribing Information updates and its submission to CDSCO as per TSC timelines 2. Liaise with GRA Pharma / Vaccines for Regulatory requirements, feedback, Vault updates, etc. 3. Ensure regulatory compliance to requirements of Drugs and Cosmetics Act for GSK products approved by DCGI. 4. Systems and Processes: . Track and maintain the product lifecycle on local XL database for the projects assigned . Track submission status & follow-up on local XL database on Regulatory Vault . Ensure Archival of submissions, correspondences and any miscellaneous communications with the authority in Regulatory Vault 5. Support implementation of QMS compliant process for regulatory affairs function for the relevant identified activities. 6. Identification and forwarding all relevant Quality and Regulatory Intelligence (QRI) received to EVP Regulatory Affairs/designee for assessment, communication and acting upon relevant intelligence which may present a potential risk or opportunity to GSK, require GSK input to influence new requirements or require GSK to make changes to ways of working 7. Ensure compliance to KPIs by periodic monitoring of database systems such as Regulatory Vault 8. Timely completion of RA training, modules and SOPs Qualification Preferably Degree in life sciences, Pharmacy or Biomedical discipline. Experience Requirements/skills - Professional experience with 3-5 years of relevant regulatory experience - Up-to-date regulatory knowledge required to do the job as described above, SUGAM portal handling experience - Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives - Project management skills - Good communication skills - both oral and written - Demonstrate strong teamwork ability and able to execute role independently - Task oriented with learning attitude 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 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\'re 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. 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