Key Responsibilities -

• With management oversight, accountable to deliver to Project Lead, Senior Submission Coordinator or GRL/ Regional Rep/ EU Agent/ C&EP TG/LOC (or equivalent) with input from Functional teams (e.g. CMC/Clinical/nonclinical etc.) for delivery of assigned submissions to agreed timeframes and appropriate content for Rest of the world (ROW) markets.
• Responsible for the coordinating the maintenance activities associated with an approved product for one or more of the following submission types: product renewals, label harmonisation, PBRER submissions, Site Registrations/Site Renewals, Tenders, Variations, PREPs etc. 
• Accountable to follow GSK ways of working/process Written Standards and develop understanding to achieve right first-time delivery.
• Utilizes Regulatory intelligence resources to determine MSR data package requirements and ensure they are fit for purpose for assigned submissions, where required.
• Regular communication with line manager or technical lead/Functional teams/LOCs (or equivalent) to execute agreed dossier strategy related to assigned deliverables and escalate any issues with business impact (e.g. submission package availability, change in local requirements).
• With management oversight, ensures quality of both own and submission team’s work and compliance with regulatory guidelines and process as they apply to the role.
• May be required to simultaneously manage multiple project assignments of varying complexity.
• Demonstrate learning agility to develop understanding of internal/external Regulatory environment.
• Demonstrate ability to work collaboratively and build organisational networks.
• Proactively attends Knowledge Exchanges and training sessions to develop broader knowledge of Regulatory Affairs and associated processes.
• May be required to participate in process improvement initiatives.

Basic Qualifications-

• Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment.
• 1-3 years of relevant experience.
• General understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Developing understanding of regulations, guidelines, procedures. and policies relating to registration and manufacturing of pharmaceutical and vaccines products.
• Proficiency using RIM systems or learning agility to quickly develop required skills.
• Strong organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
• Good 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 related to assigned submission types, reflecting recent GSK experience.
• Ability to build effective working relationships and work in a matrix environment effectively.
• Demonstrated ability and flexibility to proactively manage workload, timelines and identify priorities.
• Ability to work on multiple projects simultaneously.

Other Qualifications -

• Service orientation, customer-focused.
• Ability to utilize available information resources, both internal and external, to find solutions to unique scenarios that are not specifically documented.

Why GSK?

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

  
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 “gsk.com”, you should disregard the same and inform us by emailing [email protected], so that we can confirm to you if the job is genuine.