Are you looking for an opportunity to support a regulatory environment where you will be a part of cost reduction initiatives and ensure submission of packages are generated and provided to markets? If so, this is the role for you.
As Regulatory Affairs Executive you will be responsible the operational support to relevant Cluster within EM Partner Markets organization, including oversight and coordination of the operational matrix across Content Delivery, Region and Regulatory Third (3rd) Party
Partners. To ensure that all regulatory processes are developed and implemented, ensuring continuity of supply and
conformance to applicable Regulations, Regulatory standards and governance.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Key Responsibilities:
- Management of marketing authorizations (MAs) and coordination of associated activities for assigned markets including the primary interface with Content Delivery and 3rd Party Service
- Provider to support regulatory submissions to local regulatory agencies.
- Effective planning and tracking of regulatory activities for defined markets.
- Ensures that GSK Labeling (PI/PIL) is compliant with MA and with regulatory requirements and available in local language as applicable.
- Co-ordinates the completion of local language translations by 3rd Party CRO (as applicable)
- Ensures product information is compliant with MA and product pack changes are implemented in compliance with regulations and aligned to supply chain planning
- Co-ordinates all regulatory submissions and commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.
- Co-ordinates with Content Delivery the management of product registration documents and agency correspondence in regulatory databases and repositories.
- Builds and maintains effective relationships with, and provide considered regulatory advice, leadership, and expertise to cross functional stakeholders
- Effective communication, collaboration, planning and oversight of Regulatory Third-Party service providers to achieve Regulatory objectives and meet compliance standards
- Participation and compliance in internal and external projects and activities.
- Ensure compliance against GSK’s Regulatory internal control framework:
- management of GRA KPIs and Third Party KPI’s.
- risk & issue management & escalation
- compliance with written standards and Training.
- participation and Compliance with Audit & Assessment program.- document management- Monitor and keep abreast of changes in the regulatory environments. Provide intelligence to relevant stakeholders and central teams on potential impact changes in the regulatory environment in the region .
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in in scientific discipline experience.
- Min. 3 - 4 years of relevant experience in Regulatory Affairs.
- Fluent English language skills (speaking and writing).
- Fair command of French language (speaking and writing). is preferred.
- Knowledge of the policies and regulatory climate in relevant Cluster within EM Partner Markets organization
- •Experience gained across multiple markets is preferred.
- •Experience of working effectively in a matrix across functions.
- •Experience of working with Regulatory Third Parties is preferable
- •Effective collaboration and negotiation with regulatory agencies.
- •Work in complex regulatory environment. Able to anticipate possible changes in the regulatory environment (relating to product development, NPI, and market access) proactively, to monitor their implementation, to assess and communicate possible risks and to prepare the mitigation strategy.
- •Well-developed and demonstrable skills working as a member of a multi functional team.
- Ability to multitask and excel in cross-functional settings and to manage multiple issues in a fast-paced environment.
- The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management.
- Proven track record of effective collaboration with the regulatory agencies and a history of success in gaining product approvals and defending established products;
- Ability to read, analyze and interpret complex regulatory documents and to respond effectively to sensitive inquiries or complaints;
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.
Contact information:
You may apply for this position online by selecting the Apply now button.
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