Job Description

As a Regulatory Affairs Executive, you will provide Operational support to the relevant Cluster (particularly Sri Lanka & Maldives) within GSK\'s Emerging Markets Partner Markets organisation, including oversight and coordination of the operational matrix across Content Delivery, Region and Regulatory Third Party Partners (3Ps). Support of NDAs filings & LCM in compliance with local regulations.To ensure that all regulatory processes are developed and implemented, ensuring continuity of supply and conformance to applicable Regulations, Regulatory standards and governance.Key Responsibilities:

• Management of marketing authorizations (MAs) and coordination of associated activities for assigned markets (Sri Lanka & Maldives) 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 Sri Lanka & Maldives primarily.
• 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\xe2\x80\x99s
• Risk & issue management & escalation
• Compliance with written standards and Training
• Participation and Compliance with Audit & Assessment programs
• 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:

• 3-5 years of regulatory experience with Sri Lanka & Maldives regulations.
• Fluent/Native level proficiency in Sinhala (to facilitate communication with local third party(s) and ability to review local artwork within Sri Lanka).
• Fluent/Native English
• Effective collaboration and negotiation with regulatory agencies.
• Experience working in a 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.
• Degree or equivalent experience or qualification, with a Scientific focus/discipline.

Preferred Qualifications:

• Experience supporting multiple markets.
• Experience working effectively in a matrix organization.
• Experience working with Regulatory Third Parties.

Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 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\xe2\x80\x99s 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 \xe2\x80\x93 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.Important notice to Employment businesses/ AgenciesGSK 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.

GlaxoSmithKline