Global Submission Senior Manager

Employer
GSK
Location
Research Triangle Park, North Carolina
Salary
Competitive
Closing date
May 25, 2022

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Sector
Pharmaceutical
Organization Type
Corporate
Jobseeker Type
Professional
Site Name: Upper Providence, Belgium-Wavre, UK - London - Brentford, USA - North Carolina - Research Triangle Park Posted Date: Mar 3 2022 As Senior Global Submission Manager, you will 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 may also mentor/coach less experienced Global Submission Managers. Accountable to Global Regulatory Lead and Global Regulatory Affairs staff for the project management of major complex regulatory submissions Performs scenario planning when multiple regulatory strategies are being considered and proposes as necessary delivery strategies to achieve accelerated timelines. Maintains or provides inputs into plans which drive strategic resource planning 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 timeframes, and credible dispatch and Health Authority approval dates for key markets Leads 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. 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. Provides guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets Utilizes 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. 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. Participates in discussions/meetings with Regulatory Authorities, as required, to develop and communicate submission strategies for applications. Why you? Basic 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 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. 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: If you have the following characteristics, it would be a plus: 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. 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 Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest 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. *LI-GSK #VaccinesRD 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 Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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.

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