Submission Manager
1 miesiąc temu
Submission Manager
Works closely with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), global submission teams and Local Operating Company regulatory contacts to deliver submissions (mostly EMAP New Files & Variations) 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 the GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices 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, label harmonisation, 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 liaise with Regulatory Agencies to resolve issues in relation to their accountabilities May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development) 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 initiativesBasic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Minimum level: Degree in a biological, healthcare or scientific discipline Extensive experience within the drug development environment General 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 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 timelinesPreferred Qualifications:
If you have the following characteristics, it would be a plus:
Preferred level: Bachelor degree or higher in biological or healthcare science Excellent written and verbal communication skills and ability to present information in a clear and concise manner Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines. Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management tools Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams 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.At GSK we offer a wide range of additional benefits:
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. Sports cards (Multisport) Possibilities of development within the role and company’s structure Personalized learning approach (internal trainings, 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
#LI-HYBRID
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/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.
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