LOCAL STRATEGIC REGULATORY SPECIALIST

Site Name.
Mexico City Torre Mitikah Posted Date.
Dec The Local Regulatory Specialist is responsible for providing and support in the set-up and execution of the regulatory strategy for all clinical trials, across all therapeutic areas to achieve the Study Start-up process.
This includes, but it’s not limited to the oversight of the following processes.
submission of the Country Core Package Complete to the Ethics, Research and Biosafety Committees, preparation and submission of the I nitial Clinical Trial Application to the Local Regulatory Authority and support ongoing activities during site maintenance and close-out.
Responsibilities.
This position gives you the opportunity to lead key activities to advance YOUR career, the main ones are.
Responsible and accountable with local study teams in coordinating the planning, start-up and maintenance of regulatory operational activities involved in clinical studies, applying deep technical expertise and understanding of local regulatory environment to drive delivery of business objectives in accordance with GSK written standards.
Responsible for setting up the appropriate submissions’ strategy for the study in collaboration with the local study team.
providing insights to the study team to ensure the best possible outcome for regulatory and/or ethics committee submissions.
Responsible to work closely with the local teams ensuring accurate planning, prioritization, anticipating and mitigating risks ensuring the timely issue resolution.
Responsible for preparation and review of all documentation required for regulatory processes (e.
.
ethics, research and biosafety committees, Ministry of health, etc).
To connect with local internal and external experts to stay up to date with changes in regulations or submission requirements, capitalizing on learnings from past submission outcomes and continually improving future submissions.
Where applicable, become an active member in local external think tanks, bodies, and agencies to support the local simplification and/or acceleration of the regulatory and/or ethics committee submission process.
To coordinate with study and site related processes (e.
.
handling regulatory queries), assisting to the LDL with submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs) and maintain communication with RA and Sites to ensure all regulatory requirements are met in timely manner throughout the study.
Accountable for local activities required in the monitoring of study milestones at each stage; Input and oversee clinical study tracking systems including but not limited to.
Regulatory Vault, DIGIPRIS, Regulatory submission tracker, Study version control log, etc.
As an active participant of clinical study teams, engage in local study meetings during the life of the study to obtain general knowledge about the study and be responsible for given tasks.
Accountable for acquiring/maintaining an optimal level of knowledge of GSK tools and systems to effectively manage them.
¿Why You? Your Qualifications.
Bachelor’s degree or equivalent.
Broad experience in clinical trial applications of clinical trials to Cofepris Strong written and verbal communications skills are required in English and local language of the countries.
Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment.
Works in an environment that is constantly evolving with new processes and systems, internally and externally, and adapts to these changes quickly and efficiently.
Demonstrates track record in quality decision-making and problem resolution.
Able to set and manage priorities, resource and performance targets of local study deliverables.
Recognizes potential risks and can implement effective mitigation strategies.
Deep knowledge of Mexican regulations for clinical research.
Preferred Qualifications.
MBA or equivalent.
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.
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