Regulatory Global Submission Manager

仕事内容

Site Name: UK - London - Brentford, Belgium-Wavre, Italy - Siena, Italy - Verona

Posted Date: Jan 31 2023

342141 Regulatory Global Submission Manager / Project Manager

This is an excellent opportunity for either an established Project Manager in the Life Sciences industry or Regulatory Affairs professional looking to join a truly global team/role working across multiple therapy areas.

The job holder will work with global submission teams and third parties to project manage regulatory submissions (including global marketing applications, product line extensions and supplements) from submission through to approval, ensuring that applications and dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations and guidance and within GSK SOPs and working practices.

In this role you will

• Be accountable to Global Regulatory Lead and Global Regulatory Affairs staff for the project management of major regulatory submissions
• Perform scenario planning when multiple regulatory strategies are being considered
• Maintain or provides inputs into plans which drive strategic resource planning
• Through collaboration with contributing functional lines, create and maintain a Global Submission Plan that captures detailed list of dossier content, key activities and timelines associated with delivery of that content, target governance board review timeframes, and credible dispatch and Health Authority approval dates for key markets
• Lead submission planning discussions, ensuring team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities and components, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process.
• Provide various visuals, reports, scorecards, etc, to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders.
• Provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets
• Utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated GSK systems and planning software to ensure teams meet aggressive target submission dates by proactively focusing on critical path analysis, hand offs, scenarios, and reducing “rework” to avoid costly time delays.
• Be responsible for understanding, adhering to, and advising others on global Regulatory Authority regulations and guidance associated with electronic submissions, which differ across regions and Regulatory Authorities.
• Participate in discussions/meetings with Regulatory Authorities, as required, to develop and communicate submission strategies for applications.
  
  

Closing Date for Applications: 14th February 2023 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Why you?

Qualifications & Skills:

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

• Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment
• Project management experience in the pharmaceutical industry or in a regulatory environment.
• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• General knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV
• Familiarity with Microsoft Project and/or other project management tools
• Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
• Proven ability to think flexibly in order to meet constantly shifting priorities and timelines.
• 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.
• Effectively lead multidisciplinary team meetings and drive discussions regarding submission content, timelines, resource allocation, risk management, etc.
• Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stake holders to ensure transparency of submission progress/status.
• Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
  
  

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Global / RoW Regulatory experience
• Demonstrated leadership and negotiation skills with ability to persuade and influence others (regardless of level) in achieving team objectives.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
• Sense of urgency and ability to work well in high pressure / high stress situations
  
  

Why GSK?

At GSK, we have delivered unprecedented change over the past four years - to improve R&D productivity and performance, transform commercial execution and to , strengthen our leadership and reshape our organisation. Now, we’re getting ready to deliver the most significant change to our company in over 20 years. We’re on track to separate and create two ambitious new companies in 2022:A new GSK with a leading portfolio of vaccines, specialty and general medicines, and R&D based on the science of the immune system and genetics; and a new world-leading consumer healthcare company built on brands and innovation and delivering better everyday health.

With new ambition comes new purpose. GSK will unite science, talent, and technology to get ahead of disease together. We’ll be a company where outstanding people thrive, delivering strong, sustainable returns to our shareholders and with the power to improve the health of more than 2.5 billion people over the next 10 years.

All of this depends on our people and our culture. A culture that is ambitious for patients– so we deliver what matters better and faster; where we are all accountable for our impact and supported to succeed; and where we do the right thing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

R&D

R&D At GSK, we want to find new medicines and vaccines in ways that are faster, more effective and more predictable.

We start with what matters most, the science. Our approach to R&D focuses on science related to the immune system, the use of human genetics, and advanced technologies. Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. We have pivotal study starts in 2021 for our RSV vaccine in older adults, COVID-19 assets, long-acting anti-IL-5 antagonist, daprodustat, and dostarlimab. In oncology, momentum is building with 15 potential medicines in trials, including nine immuno-oncology and three cell therapies.

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.

Technology can help us find patterns in genetic data better and faster. We’re using machine learning to unlock the potential of complex genetic data with new levels of speed, precision, and scale. And we’re one of the first biopharmaceutical companies to have created an in-house AI lab dedicated to drug development.

Even with the knowledge, tools, and resources within GSK, there’s always a benefit to new perspectives. That’s why we’re increasingly partnering with and hiring outstanding people from cutting edge fields like tech, data-science and academia. In 2018, GSK formed an exclusive, highly innovative collaboration with 23andMe, the world’s leading consumer genetics and research company. Other partners include: the Altius Institute; the UK Biobank, which is generating anonymized genetic sequence data from 500,000 volunteers; and the Open Targets Consortium, the mindset and approach of smaller, more agile startups.

Find out more: Our approach to R&D.

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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