Job title: Regulatory Specialist III – MSR Coordination
Company: GlaxoSmithKline
Job description: Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Jun 14 2022 Ready to help shape the future of healthcare? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Cons
Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Jun 14 2022 Ready to help shape the future of healthcare 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: Provides support for GRA regulatory delivery activities (e.g., Variations, Product Expansion dossiers, Renewals and regional projects) of assigned projects with management input. Supports Global Regulatory by authoring and coordinating appropriate MSR packages for global regulatory submissions with appropriate guidance from supervisor, as necessary. May have training responsibilities for new staff on established departmental processes. Key Responsibilities: With minimal input from manager, executes agreed dossier strategy related to MSR packages Liaise with MSR suppliers & customers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner. With minimal input from manager, manages multiple project assignments supporting Variations, Product Expansion dossiers, Renewals and regional projects simultaneously MSR packages/documents will range in complexity With minimal input from manager, completes data assessment to ensure MSR package is fit for purpose, identifies risks associated with submission data and MSR packages. Communicates with line manager to identify issues that have business impact. May have responsibilities for reviewing work of peers and may identify improvement opportunities for Regulatory processes, policies and systems. Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical and vaccines products Understands internal/external Regulatory environment Actively builds an organizational network. Communicates across GSK, with minimal input from manager regarding projects and new requirements impacting MSR deliverables Knowledge/ Education / Previous Experience Required: A. Educational Background : 1. Minimum Level of Education – Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment Area of Specialization – Chemistry, pharmacy or other related science or technical bachelors degree. Why is this Level of Education Required – Appropriate for the role 2. Preferred Level of Education – Masters degree or higher in biological or healthcare science Area of Specialization – Regulatory, Pharmaceutics, or other related science or regulatory affairs. Project Management, Communication Why is this Level of Education Preferred – Appropriate for a scientific environment B. Job-Related Experience: Minimum Level of Job-Related Experience required Minimum 0 – 6 years of relevant experience Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions. Proven ability to work on multiple projects simultaneously. Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. Global/ EMAP Regulatory submission experience – Knowledge of regulatory agency guidelines Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines Excellent written and verbal communication skills and ability to present information in a clear and concise manner Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience Ability to build effective working relationships and work in a matrix environment effectively Ability to think flexibly in order to meet constantly shifting priorities and timelines. Why is this Level of Experience Required – These basic skills are fundamental to delivery of work in MSR team C. Other Job-Related Skills/Background Excellent attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines. Demonstrated ability to think flexibly in order to meet constantly shifting priorities and timelines. Demonstrates the following behaviors: Customer focus and Enable and drive change 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. 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 GlaxoSmithKilne (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 ‘gsk.com’, you should disregard the same and inform us by emailing [HIDDEN TEXT], so that we can confirm to you if the job is genuine.
Expected salary:
Location: Bangalore, Karnataka
Job date: Fri, 17 Jun 2022 22:10:26 GMT
Apply for the job now!