Regulatory Global Submission Manager

Job Title Regulatory Global Submission Manager Key Responsibilities In close collaboration with Regulatory Asset Oversight GRL and RMT provides project management support at submission level drives execution of agreed plans and ensures timely and compliant delivery of submissions for US EU and Rest of the World ROW markets Outlines content deliverables target timelines submission preparation activities and interdependencies for the various functional lines within the RMT Performs critical path analysis and scenario planning to evaluate multiple strategies as necessary to achieve accelerated submission timelines Collaborates with publishing and other operational teams to ensure technical compliance and adherence to timelines for preparation and final dispatch of dossiers Maintains submission content plans within Reg Vault and Smartsheet ISP for managing major submissions in primary markets and to drive baseline dossiers for the market expansion team in ROW markets Leads submission planning meetings to ensure timely and compliant execution of global submission plans and to identify and quickly remediate any issues or blockers Key contributor to foundation meetings regulatory matrix team meetings other project-related meetings with ability to influence key aspects of submission strategy internal processes and submission content Must work collaboratively with staff from other functions and should be capable of working to senior levels in process development functions in provision of advice interpretation of relevant guidance researching topics and resolving issues Possess in-depth knowledge of GSK processes ways of working and provide training consultation and solutions within the team department as well as externally outside the department Independently and confidently executes agreed dossier strategy related to assigned deliverables with minimal input from manager escalate any issues with business impact and offers potential solutions Ensures alignment and clear understanding of Regulatory Requirement Legislation Guideline for EU US and ROW markets Must be able to simultaneously manage multiple project assignments of varying complexity May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities Support peers and identify improvement opportunities for Regulatory processes policies and systems Minimum Level of Job-Related Experience required Demonstrated experience in submission management planning for major pharmaceutical and or vaccine assets as an integral member of Regulatory project teams Knowledge in Regulatory Affairs covering a breadth of global regulatory procedures particularly those related to NCE NBE and major line extensions Must be proficient with regulatory submission management concepts and the connections between various regulatory systems and associated processes Demonstrated proficiency with submission planning tools Smartsheet MS Project Regulatory systems and related reporting software Ability to effectively interact through different levels in the regulatory organization and with stakeholders outside of regulatory with ability to persuade and influence others in achieving team objectives Must be able to work with minimal supervision in a complex organization driving the delivery of key departmental objectives Excellent organizational skills attention to detail and commitment to deliver high quality output even under pressures sometimes demanded by regulatory deadlines Excellent written and verbal communication skills and ability to present information in a clear and concise manner Ability to interpret and advise on guidelines and requirements on a global basis reflecting recent GSK experience Ability to build effective working relationships and work in a matrix environment effectively Demonstrated ability to think flexibly to meet constantly shifting priorities and timelines Demonstrated ability to proactively manage workload timelines and identify priorities Build relationships with relevant internal functions Proven ability to work on multiple projects simultaneously At GSK we are committed to creating an inclusive workplace where everyone feels valued supported and inspired to achieve their best If you are ready to make a difference and contribute to our mission we encourage you to apply today Why GSK Uniting science technology and talent to get ahead of disease together GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together We aim to positively impact the health of 2 5 billion people by the end of the decade as a successful growing company where people can thrive We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines We focus on four therapeutic areas respiratory immunology and inflammation oncology HIV and infectious diseases - to impact health at scale People and patients around the world count on the medicines and vaccines we make so we re committed to creating an environment where our people can thrive and focus on what matters most Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people Inclusion at GSK As an employer committed to Inclusion we encourage you to reach out if you need any adjustments during the recruitment process Please contact our Recruitment Team at to discuss your needs 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 It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way GlaxoSmithKline does not charge any fee whatsoever for recruitment process Please do not make payments to any individuals entities in connection with recruitment with any GlaxoSmithKline or GSK group company at any worldwide location Even if they claim that the money is refundable If you come across unsolicited email from email addresses not ending in gsk com or job advertisements which state that you should contact an email address that does not end in gsk com you should disregard the same and inform us by emailing so that we can confirm to you if the job is genuine