Regulatory Manager, Submission Coordination

Site Name: Mexico City Torre Mitikah Posted Date: Dec 13 2022 Your Responsibilities: This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are Support of the strategic resource management process, by delivering high quality integrated Regulatory Development Plans (RDPs) by operationalizing the Global Regulatory Strategy into the RDP Ensure the regulatory functional line planning at the project level, proactively partner with other functional plan owners/project managers from Medical, Safety, Clinical, etc., to ensure awareness of regulatory deliverables and alignment across all plan types within a project group Manage HR aspects for a team of direct reports including recruitment, training and development Manage and take accountability of workload within assigned team and work with other team leads within functional area to address resource challenges Supervise and support the work of team members through routine interactions with functional leads Working with the functional lead, ensure staff are delivering assigned submissions and tasks including supporting Submission coordination objectives of quality and compliance Ensures the implementation of submission coordinator working practices and procedures aimed at simplifying processes and maintaining quality and capable of leading initiatives associated with submission coordination in alignment with the group objectives Generate appropriate metrics and key performance indicators for the team, and use metrics to develop and enhance capability within the Submission Coordination group and the GRC Why you? Basic Qualifications: We are looking for professionals with these characteristics to achieve our goals: University Degree in a biological, healthcare, or scientific discipline. 7+ years of experience In Regulatory Submissions in the Pharmaceutical Industry Experience leading Regulatory and/or Project Managers Teams Advanced English Level. Experience supporting Labelling and Technical Variations Preferred Qualifications: However, if you have the following, it would be a plus: Veeva Vault experience. Planisware experience If you feel this is your next career move, please apply up to December 30th, 2022. Why GSK? 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more: Annual Report 2021 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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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