Basic Qualifications:
15+ Years of professional experience.
Have an understand the Regulatory Operations landscape.
Have a successful track record of delivering IT and Business Transformation.
Location: Bangalore.
Are you looking for a highly visible regulatory leadership role where you can build advocacy and accelerate regulatory compliance on an international scale? If so, this Director, Regulatory Platform Innovation role could be an exciting opportunity to explore.
As a The Director, Regulatory Platform Innovation, should possess a digital mindset, understand the Regulatory Operations landscape and have a successful track record of delivering IT and Business Transformation initiatives, using various methodologies, in a fast-paced environment. This pivotal role requires strong leadership, delivery expertise, technological acumen, and deep regulatory knowledge within the pharmaceutical industry. The successful candidate will lead the scoping, integration and delivery of innovative regulatory programs of work, leveraging emerging technologies to enhance regulatory processes and advancement. This role is crucial for driving strategic innovation that aligns with GSK's mission and regulatory requirements.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Team Management:
Lead, mentor and develop a high-performing team, fostering a culture of inclusivity, collaboration and innovation.
As applicable, provide leadership and guidance to matrix teams, promoting collaboration and a shared commitment to achieving project goals.
Where applicable, provide day-to-day line management of staff, supporting continuous improvement and career development.
Reporting lines may vary - team members may have direct, indirect and/or matrix reporting lines
Leadership:
Lead the planning, execution, and delivery of regulatory technology and innovation programs, ensuring projects/programmes are designed to deliver maximum value and are aligned with strategic objectives and regulatory standards.
Delivery methodologies may vary, and thus roles may adapt accordingly (e.g., This role may play the role of a ‘Product Manager’, Product Owner’ etc.)
Initiatives may span across multiple teams and functions and may require strategic decision-making (related to e.g., budget allocation, resource mgmt., process improvement) and will require influencing across departments.
Project/programme Management:
Oversee the progress of projects/programmes with respect to time, scope, budget, risk, quality and compliance, holding leaders and teams to account to ensure execution in accordance with the plan
Develop realistic roadmaps/plans with agreed deliverables, ensuring alignment across systems, data, process and people.
Establish key metrics and KPIs for evaluation of project/programme performance and conduct collaborative retrospectives as needed. Identify areas of improvement and implement corrective actions accordingly.
Manage budgets, forecasts and resource allocation to optimise efficiency and cost effectiveness
Communicate project/programme status, updates, and outcomes to stakeholders at various levels of the organization. Prepare and present progress reports, executive summaries, and other documentation as required.
Ensure a user-centric, iterative delivery approach based on business value, with tangible measurable success metrics/KPIs.
Governance and Risk Management:
Establish and facilitate project governance frameworks to ensure alignment with goals, drive decision making and facilitate the resolution of risks.
Identify and mitigate risks, resolving issues promptly to minimize impact on project timelines and outcomes. Implement risk management strategies and contingency plans.
Cross-Functional/Vendor Collaboration:
Collaborate with cross-functional teams, including (but not limited to) Tech, R&D, Quality Assurance, and external partners, to define project/programme scope, objectives, and deliverables.
If applicable, lead the engagement of third-party vendors, inc. relationship management, negotiation of contracts, compliance with procurement/legal teams, influencing of vendor roadmaps and dependencies, and negotiation of budgets.
Manage relationships with external vendors, consultants and GSK strategic partners as needed, ensuring they deliver quality work on time and within budget.
Facilitate impact assessments and partner with Process, Data and Business Change teams as needed to ensure seamless delivery into the business with minimal disruption to end users and business operations
Compliance Assurance:
Ensure compliance with relevant GSK regulations, policies and standards. Partner with GSK Quality teams to ensure compliance. If needed, represent Regulatory Platform Innovation team in inspections/audits/councils
Stay updated on regulatory changes and ensure projects adhere to new regulations.
Continuous Improvement:
Stay informed about industry trends, regulatory developments, emerging technologies (e.g. AI, automation, machine learning) and advanced digital tools.
Actively seek out areas of improvement, driving forward innovation. Present recommendations and investment proposals to senior management and stakeholders, clearly articulating the strategic value and expected outcomes.
Foster a culture of continuous improvement by actively and regularly engaging with user communities, seeking feedback and improvement opportunities.
Qualifications and Skills
Knowledge and experience of project management tools (E.g. Smartsheet). Holds Project Management or Scaled Agile certifications (e.g., PRINCE, PO/PM)
Service/customer-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
Possesses a digital mindset embracing technology/tools as a catalyst for innovation, efficiency and growth
Focuses on value - Identifies and prioritizes initiatives based on value to the company
Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way.
Experience of delivering large scale, complex IT and Business Transformation programs (System, Data, Process, People), working with different methodologies as needed
Proven aptitude for defining realistic and achievable plans to manage multiple programs of work with an awareness of prioritization and impact.
Demonstrated ability to think flexibly and innovatively to meet constantly shifting priorities and timelines.
Proven ability to take an organized and methodical approach to problem solving/trouble shooting
Excellent attention to detail and commitment to deliver high quality output, even under pressure.
Demonstrated ability to build, mentor, and manage high-performing teams
Knowledge and experience of regulatory systems including the validation requirements associated with GxP systems.
Knowledge and experience of JIRA and effective requirements decomposition (Epic -> Feature -> User Story -> Task)
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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