Submission Lead

SUBMISSON LEAD works closely with global submission teams, Local Operating Company regulatory contacts, Global Regulatory Lead (GRL) or Regulatory Matrix Team (RMT) to deliver e2esubmissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices.

Mentors/coaches/trains other team members and reviews work to ensure right first-time submissions.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…

• Accountable to Global Regulatory staff for the delivery of Marketing Application, to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices.
• Responsible for presenting and actively communicating requirements & policies for various types of submissions to all stakeholders and champions as needed.
• Responsible for coordinating MSR for various types of submission and independently and confidently executing agreed dossier strategy.
• May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations/renewals/variations, periodic benefit risk evaluation reports (PBRER) submissions etc.).
• May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
• May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets.
• May be required to lead or participate to process improvement initiatives.
• May be required to take on additional Project Management responsibilities if identified as Single Point of Contact (SPOC).

Why you?

Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Degree in a biological, healthcare or scientific discipline or Extensive experience in the Regulatory Affairs area.
• Broad understanding of the pharmaceutical industry and R&D processes and objectives.
• Broad knowledge of Regulatory Affairs responsibilities from post approval phase.
• Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
• Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
• Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
• Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.
• Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management, etc.

Why GSK?

What we offer:

• Career at one of the leading global healthcare companies
• Hybrid work ( 2/3 days per week from the office)
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible counterparts
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• Personalized learning approach (internal training, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities). 
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits every day

#LI-GSK

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As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [email protected] to discuss your needs.

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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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