Senior Manager, Regulatory Global Submission

As Senior Manager, you work with global submission teams and third parties to project manage complex 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 guidances and with GSK SOPs and working practices.

You mentor/coach Global Submission Managers.

• You are accountable to Global Regulatory Lead and Global Regulatory Affairs staff for the project management of major complex regulatory submissions

• You perform scenario planning when multiple regulatory strategies are being considered and proposes as necessary delivery strategies to achieve accelerated timelines.

• You maintain or provide inputs into plans which drive strategic resource planning

• Through collaboration with contributing functional lines, you 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

• You 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.

• You 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.

• You provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets

• You 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.

• You are 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.

• You participate in discussions/meetings with Regulatory Authorities, as required, to develop and communicate submission strategies for applications.

Basic Qualifications:

• 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.

• Detailed understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.

• Extensive knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV

• Global / RoW Regulatory experience

• Expertise with Microsoft Project and/or other project management tools

• Excellent written and verbal communication skills and ability to present information in a clear and concise manner

Preferred Qualifications:

• 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.

• Demonstrated leadership and negotiation skills with ability to persuade and influence others (regardless of level) in achieving team objectives.

• 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.

• 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

• Li-GSK
• VxRD

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.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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.

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