At a Glance
- Tasks: Coordinate labelling for products, ensuring compliance with regulations and quality standards.
- Company: Join a leading life sciences company focused on innovation and collaboration.
- Benefits: Gain valuable experience in regulatory affairs with opportunities for professional growth.
- Other info: Dynamic role with a focus on digital solutions and global collaboration.
- Why this job: Be a key player in product labelling, impacting health and safety across markets.
- Qualifications: Life sciences or pharmacy background; strong attention to detail and problem-solving skills.
The predicted salary is between 30000 - 40000 £ per year.
The HUB Labeling Manager will be responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products for their assigned markets and updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements. This role may act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence in collaboration with other Hub Labeling Managers. Additionally, this role will serve as an SME for the use and development of current and new global tools, technologies and processes to support label development, submission and approval; with a particular focus on digital solutions.
Responsibilities
- Maintains system management for labeling activities including Global Document Management System (GDMS) and approved labeling tracking system.
- Maintenance of workflow management tools and mailboxes.
- Monitors system data integrity and quality checks.
- Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs.
- Produces other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supporting documentation.
- Performs QC check of other colleagues’ work.
- Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
- Meets defined targets on productivity, quality and compliance, as set by and overseen by management.
- Utilizes regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from others.
Qualifications
- Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
- Fluency in English language important however multi-language skills are advantageous.
Required Skills
- Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access.
- Knowledge of key regulatory and labeling principles and local regulations.
- ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs; preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs.
- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
- Demonstration of attention to detail and problem-solving skills.
- Proven technical aptitude and ability to quickly learn new software.
- Proven technical aptitude and ability to quickly learn regulations and standards.
- Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label.
- Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important.
- Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages preferred.
- Demonstrated project management, attention to detail and problem-solving skills.
- Proven strength in logical, analytical and writing ability essential.
Labelling Co-Ordinator in Dorking employer: Russell Tobin
As a Labelling Co-Ordinator at our Walton Oaks hub, you will join a dynamic team dedicated to regulatory excellence and innovation in labelling processes. We pride ourselves on fostering a collaborative work culture that values employee growth through continuous learning opportunities and the use of cutting-edge digital tools. With a focus on quality and compliance, we offer a supportive environment where your expertise will be recognised and your contributions will directly impact our mission to deliver safe and effective products to the market.
StudySmarter Expert Advice🤫
We think this is how you could land Labelling Co-Ordinator in Dorking
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We think you need these skills to ace Labelling Co-Ordinator in Dorking
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Russell Tobin!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Russell Tobin that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Russell Tobin!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Russell Tobin, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Russell Tobin
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Russell Tobin that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Russell Tobin’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
