Job title: Regulatory Affairs Manager

Company: GlaxoSmithKline Pte Ltd

Job description: Job Description : Site Name: Field Worker – CHN Posted Date: Mar 17 2022 Is there any greater challenge than getting ahead of disease? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader

Job Description : Site Name: Field Worker – CHN Posted Date: Mar 17 2022 Is there any greater challenge than getting ahead of disease At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact stronger and more sustainable shareholder returns and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster accountable for impact – with clear ownership of goals and support to succeed and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. Job Purpose: Deliver regulatory strategy of key assets identified for India and achieve regulatory milestones according to plan for Pharmaceutical business including Specialty (Oncology, Immunology and Respiratory). Key Responsibilities: 1. Regulatory activities for: New product launches (involving marketing authorization and Import & Registration) Line extensions and label expansions Clinical Trial Applications (GCT and Local CTs) 2. Support business continuity via management of renewals, CMC/labeling variations, post approval commitments for assigned portfolio. 3. Oversee implementation of regulatory processes/systems as well as governance process within the team for assigned portfolio. 4.Promote development and growth of talent within the team. 5. Liaise with global as well as local stakeholders for regulatory requirements related to various submission activities. 6. Ensure regulatory compliance to applicable regulations in India. 7. Support implementation of QMS compliant process for regulatory affairs function for the relevant identified activities. Educational Background: B Pharm/ M Pharm/ M Sc Job Related Experience: 8-15 years of relevant experience 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. 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Expected salary:

Location: Mumbai, Maharashtra

Job date: Sat, 19 Mar 2022 23:41:38 GMT

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