Global submissions Manager (for major submissions)
- Luboń, Poland
Site Name: Warsaw, Poznan Grunwaldzka
Posted Date: Mar 9 2021
As a Global submissions Manager, you will work with global submission teams and third parties to project manage regulatory submissions (including global NCE/NBE marketing applications, product line extensions, Investigational New Drug applications, etc.) from submission through to approval, ensuring that applications and dossiers are prepared to the highest quality standard and in a timely efficient manner.
You will manage submission teams, lead discussion of deliverables and timings, facilitate scenario planning and perform impact analysis. You will 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 and proactively focus on critical path acceleration, efficient hand-offs, and reduction in "rework" to avoid costly time delays, while at the same time ensuring all necessary quality reviews and approvals are achieved, allowing GSK to continue producing applications to the highest quality standard.
- Accountable to Global Regulatory Lead and Global Regulatory Affairs staff for the project management of major submissions.
- Provides guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets.
- Through collaboration with contributing functional lines, creates and maintains 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 time frames, and credible dispatch and Health Authority approval dates for key markets.
- To ensure GSK's competitiveness in drug development, work with teams to identify ways to optimize and accelerate bringing products in our late-stage pipeline to market, focusing on key activities and processes from last subject last visit (LSLV) to submission and approval.
- Leads submission planning discussions, ensuring team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the inter-dependencies 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.
- Performs scenario planning when multiple regulatory strategies are being considered.
- Provides various visuals, reports, scorecards, etc. to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders.
- Works closely with data generating groups to monitor progress and ensure team is on-track to delivery according to plan. When potential issues and delays are identified, works to expeditiously find solutions in order to keep the team progressing toward the target submission time frame.
- 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.
- Facilitate post-submission after action reviews (AARs) to identify key learnings and best practices which are then used to refine and improve GSK submission processes.
- Education - preferred degree in a biological, health care, or life science discipline.
- Project management experience in the pharmaceutical industry, preferred in regulatory environment.
- Understanding of the pharmaceutical drug and vaccine development environment, and R&D processes and objectives.
- General knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV.
- Proficiency with Microsoft Project and/or other project management tools will be an asset.
- 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 and effectively interact with stakeholders 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.
- Remote work (during pandemic)
- Performance with Choice - come to the office 1 day/week (subject to discussion with the line manager)
- Important and interesting job in one of the leading global healthcare companies.
- An opportunity to play a key role in bringing new medicines and vaccines to patients.
- A position that liaises with various functional areas and culminates years of work into a marketing application that is submitted around the world.
- Possibility to work with engaged and enthusiastic people from various locations.
- Training on the newest project portfolio management software solutions and content management platforms.
- Possibilities of development within the role and company's structure.
- Benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office).
- Corporate culture based on our values: patient focus, integrity, respect and transparency.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Back to top