Director, Regulatory Global Process Owner

**Site Name**: Poznan Grunwaldzka, Canada - Ontario - Mississauga, GSK HQ, UK - Hertfordshire - Stevenage
**Posted Date**: Jan 21 2025
**Director Regulatory Global Process Owner - Labelling**

In this pivotal role, you’ll lead the design and continuous improvement of Labelling processes, ensuring they are audit-ready, efficient, and aligned with business needs. The Labelling GPO provides oversight of the full End to End (E2E) Labelling process and collaborates with Regulatory peers, Senior leaders, and Quality Leads to develop in-process controls and management monitoring strategies for relevant processes. If you’re ready to shape the future of regulatory labelling processes and make a real impact, we’d love to hear from you.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_

**In this role you will**
- Develop and maintain GRA Labelling processes to ensure compliance with global regulations and industry standards, while driving strategic direction and continuous improvement.
- Monitor and enhance Labelling process performance by designing and implementing KPIs, conducting maturity assessments, and collaborating with cross-functional teams to improve efficiency and compliance.
- Lead Labelling process improvement initiatives and drive innovation in continuous improvement programs to deliver streamlined and effective processes.
- Provide training and communication strategies, ensuring global staff and partners are equipped with up-to-date materials and resources to support their roles and system updates.
- Represent GSK externally, influencing regulatory authorities, industry groups, and vendors to shape innovative methodologies and ensure alignment with global standards.
- Support audit and inspection readiness, maintaining compliance documentation, responding to inspection observations, and fostering a culture of transparency and accountability.

**_ Why you?_**

**Basic Qualifications & Skills**:
**We are looking for professionals with these required skills to achieve our goals**:

- Qualification in a Scientific or Technical specialisation
- Extensive experience in Pharmaceutical Regulatory Affairs Labelling, with a strong understanding of global regulatory procedures and applicable requirements.
- Proven ability to operate independently and communicate effectively at all levels within an organisation, ensuring the on-time delivery of objectives and projects.
- Strong enterprise mindset, with the ability to break down silos across the organisation to maximise benefits for users and the business.
- Demonstrated project management skills, including overseeing and prioritising multiple activities across projects and customers.
- Experience working within a complex IT system landscape in a regulated environment.
- Leadership experience in team or matrix environments, with the ability to motivate and manage teams effectively through periods of change.

**Preferred Qualifications & Skills**:
**Please note the following skills are not necessary, just preferred, if you do not have them, please still apply**:

- BSc (or equivalent) in a scientific or technical discipline, PhD or PharmD preferred.
- In-depth knowledge of GSK Regulatory Affairs Labelling roles, responsibilities, and systems, with a focus on innovation and process improvement.
- Ability to leverage data to ensure patient safety, compliance, inspection readiness, and provide valuable organizational insights.
- Proven leadership and global mindset, with the ability to adapt to change and drive innovation in a fast-paced environment.
- Strong communication skills, both written and verbal, with a demonstrated ability to influence and inspire across all levels of the organization.
- Track record of building high-performing global matrix teams and driving continuous improvement through clear performance goals.
- Strong sense of urgency, with the ability to prioritize and manage emerging high-priority issues effectively.

**Closing Date for Applications - 30th January 2025 (COB)**

Please take a copy of the Job Description, as this will not be available post closure of the advert.

**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