Job title: Regulatory Associate Manager- License Maintenance

Company: GlaxoSmithKline

Job description: Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Jun 27 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

Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Jun 27 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 Responsible for the GRC regulatory delivery activities (e.g., Variations , Product Expansion dossiers, Renewals, MSRs , Annual Reports, Facilities Variations) of multiple projects across dosage forms. Represents GRC, on Regulatory Networks and Matrix Teams providing guidance to Global Manufacturing and Supply (GMS), Commercial, Quality Assurance, 3rd Party Contract Management and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers. Will serve as a mentor/trainer for new team members. Key Responsibilities Independently and confidently executes agreed dossier strategy Independently manages multiple project assignments (e.g., Variations , Product Expansion dossiers, Renewals, MSRs , Annual Reports, Facilities Variations) simultaneously assignments will range in complexity but more complex work is expected Independently completes data assessment to ensure dossier is fit for purpose. Identifies risks associated with submission data and information packages. Escalates issues with line manager that have business impact. Serves as dossier reviewer for peers and identifies improvement opportunities for Regulatory processes, policies and systems. Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. Understands internal/external Regulatory environment. Uses established organisational network. Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK. Knowledge/ Education / Previous Experience Required:- 1. Minimum Level of Education – Bachelors degree Area of Specialization – Chemistry, pharmacy or other related science or technical bachelors degree. C. Other Job-Related Skills/Background :- English language skills Knowledge of drug development and manufacturing and supply processes. Knowledge of worldwide regulatory requirements. Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager. 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: Bangalore, Karnataka

Job date: Wed, 29 Jun 2022 22:19:17 GMT

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