Role Purpose
Provide operational regulatory support across assigned markets within International Central Partner Market region, including oversight and coordination of activities across content delivery, regional teams and regulatory third-party partners.
Ensure regulatory processes are developed and implemented to maintain continuity of supply and conformance to applicable regulations, regulatory standards and governance.
Key Responsibilities
- Manage marketing authorizations and coordinate associated activities for assigned markets, acting as the primary interface with content delivery teams and third-party service providers to support regulatory submissions to local agencies.
- Plan and track regulatory activities for defined markets to meet agreed timelines and strategies.
- Ensure GSK labelling (PI/PIL) is compliant with marketing authorizations and regulatory requirements and is available in local language as applicable; coordinate completion of local language translations by third-party partners.
- Ensure product information and pack changes are implemented in compliance with regulations and aligned with supply chain planning.
- Coordinate all regulatory submissions and commitments in line with regulatory requirements and agreed strategy and timelines.
- Work with content delivery to manage product registration documents and agency correspondence in relevant regulatory databases and repositories.
- Build and maintain effective relationships, providing regulatory advice, leadership and expertise to cross-functional stakeholders.
- Oversee and collaborate effectively with regulatory third-party service providers to achieve regulatory objectives and meet compliance standards.
- Participate in internal and external projects and activities, ensuring regulatory compliance and effective contribution.
- Ensure compliance with GSK’s regulatory internal control framework, including quality management activities, management of GRA and third-party KPIs, risk and issue management and escalation, compliance with written standards and training, participation in audit and assessment programs, and appropriate document management.
- Monitor and keep abreast of changes in the regulatory environment, providing intelligence to stakeholders and central teams on potential impacts within the region.
Qualifications & Experience
Education
- Bachelor’s degree or equivalent qualification in Pharmacy, Life Sciences, or a scientific discipline.
Experience
- Minimum 4 years of relevant experience in Regulatory Affairs in Life Sciences.
- Fluent English (spoken and written); good command of French (spoken and written).
- Knowledge of policies and the regulatory climate in relevant markets within the Emerging Markets region and partner markets organization; experience across multiple markets preferred.
- Experience working effectively in a matrix environment across functions and with regulatory third parties.
- Effective collaboration and negotiation with regulatory agencies; experience working in a complex regulatory environment.
- Ability to anticipate changes in the regulatory environment relating to product development, new product introductions and market access, monitor implementation, assess and communicate potential risks and prepare mitigation strategies.
- Demonstrable experience working as a member of multi-functional teams, managing multiple issues in a fast-paced environment and excelling in cross-functional settings.
- Ability to make decisions and influence outcomes, assessing risk and business impact and exercising good judgement on when to escalate to senior management.
Skills & Attributes
- Strong knowledge of regulatory specifics, with a track record of effective collaboration with regulatory agencies and success in gaining product approvals and defending established products.
- Ability to read, analyze and interpret complex regulatory documents and respond effectively to sensitive inquiries or complaints.
- Insightful and forward-thinking, able to recognize, anticipate and discuss potential regulatory challenges with teams.
- Strong leadership expectations: able to collaborate in cross-functional settings, manage multiple issues in a fast-paced environment and provide advice and counsel in strategic decisions.
- Competent and transparent communicator with excellent written, verbal and presentation skills; fluent in English, with strong listening and comprehension skills and the ability to adapt style to the audience.
- Takes ownership, is productive, and has the courage to address potential problems proactively before they become issues.
- Strong change-management and project-management skills.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Skills
Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance
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.
Contact information:
You may apply for this position online by selecting the Apply now button.
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