Regulatory Specialist

Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization?  If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore.

As Regulatory Operations Manager, you will be responsible for leading or supporting strategic and operational Regulatory projects, which support business strategy and platform delivery.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…

• Fulfil standard, ad hoc, or complex data reporting request and design outputs.
• Assist Regulatory Business Operations (RBO) staff in delivery of projects.
• Assist RBO staff in process documentation, monitoring, and reporting.
• Maintain Team sites.
• Adhere to records retention.
• Complete appropriate training.
• Assist Regulatory Business Operations staff to optimize project plan robustness (scope, deliverables, resources, timing).
• Provide project support to meet assigned business deliverables.
• Edit existing process documentation and lead monitoring and reporting.
• Provide analysis and interpretation of information in response to requests from requestors and pursue greater data quality through identification of gaps and delivery of efficient solutions.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree.
• 3 years of pharmaceutical industry experience in a regulatory environment.
• Experience with License Maintenance as well as overall R&D processes.
• Direct experience with project planning & execution.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master's degree or MBA
• Experience working in a matrixed environment
• Demonstrated ability to engage and influence senior stakeholders.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment- to discuss your needs.

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