Are you looking for a role where you can showcase your process improvement skills? If so, this is the job for you.
As Regulatory Specialist, Country Labelling — Senior you will be responsible for leading a process improvement effort across the organization focusing on business alignment, cost and cycle time reduction as well as quality management.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
• Author and compile Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards.
• Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.
• Provide support to global and local GRA team members through preparation of other labelling documents as required
• Complete quality and consistency checks of labelling document content.
• Efficiently coordinate and manage labelling documentation and data in regulatory systems.
• Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
• Effectively communicate with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff.
• Support other regulatory functions and participate in other projects and activities as needed, such as contributing to the implementation of changes to labelling processes and evaluation of new agency labelling requirements.
• For some roles, may be required to perform translation of labelling text into identified languages.
• May become a SME in country/regional labelling content and process
We are looking for professionals with these required skills to achieve our goals:
- Bachelors degree or equivalent work experience
- 2+ years relevant experience (in pharmaceutical industry, life sciences research or regulatory).
- Experience of XML Labelling.
- The ability to understand the scientific content of complex labelling documents.
- Experience in a regulated or quality-critical environment such as pharmaceutical industry research, pharmacy, safety or regulatory
- Experience in updating and managing Regional/Country Labeling documents.
- Proficient with computer software applications
- Familiar with medical terminology
- Ability to negotiate solutions to moderate labeling issues and proactively identify improvements for labelling processes
- Knowledge of labelling regulations/requirements in 1 or more regions.
If you have the following characteristics, it would be a plus:
- Masters degree or equivalent work experience
- Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple tasks.
- Broad understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
- Regulatory document management experience (particularly experience of working with and amending Product Information/Labelling Documents).
- Experience and familiarity of working within regulatory systems and communication tools.
- Some experience of managing local and global labelling documents and submissions.
- Experience of communicating with regulatory agencies.
- Experience of EU (including Linguistic review) and US label content and requirements. 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.
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