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- Tasks: Manage and update product documents while ensuring compliance with local regulations.
- Company: Join Smartedge Solutions, a leader in IT services and consulting.
- Benefits: Enjoy flexible working arrangements and opportunities for professional growth.
- Why this job: Be part of a dynamic team making a real impact in the tech industry.
- Qualifications: Masters in Lifesciences with 5-8 years in regulatory affairs or labelling.
- Other info: Mid-senior level contract position with a focus on legal functions.
The predicted salary is between 48000 - 72000 £ per year.
Responsibilities:
- Responsible for executing the content management of core data sheet (CDS) and local product documents (LPDs).
- Responsible for updating as per the local safety signals.
- Keep up to date with regional labeling regulations.
- Authoring labelling submission package.
- Coordinate and preparation of translation in local language.
- Creation of gap analysis of the local labels and providing references of supportive literature and publications for the updated text.
- Proofread documents prepared by team.
Qualifications:
- Masters in Lifesciences or equivalent with 5-8 years of experience in regulatory affairs/labelling or equivalent.
- Knowledge of the principles and concepts of labelling, including generics, authorized generics, private labels, device/combination products, how to read and interpret HA regulations and guidance, and underlying SOPs.
- Ability to identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions.
- Must be able to construct a Company Response (MAH response) for health authority questions.
Preferred qualifications:
- Excellent communication and PC skills.
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Legal
Industries: IT Services and IT Consulting
Cloud Solution Architect employer: Smartedge Solutions
Contact Detail:
Smartedge Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Cloud Solution Architect
✨Tip Number 1
Familiarise yourself with the latest regional labelling regulations and guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in regulatory affairs and labelling. Attend industry events or join relevant online forums to connect with others who can provide insights or even refer you to opportunities at StudySmarter.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you've successfully managed labelling projects or resolved discrepancies. This will showcase your problem-solving skills and practical knowledge during interviews.
✨Tip Number 4
Research StudySmarter's current projects and values. Tailoring your conversation to align with our mission and demonstrating how your background fits into our goals can make a strong impression during the interview process.
We think you need these skills to ace Cloud Solution Architect
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Cloud Solution Architect position. This will help you tailor your application to highlight relevant experience.
Tailor Your CV: Customise your CV to reflect your experience in regulatory affairs and labelling. Emphasise your knowledge of labelling principles, your ability to identify discrepancies, and any relevant projects you've worked on.
Craft a Compelling Cover Letter: Write a cover letter that connects your background in lifesciences with the specific requirements of the job. Mention your experience with local product documents and your understanding of regional regulations to demonstrate your fit for the role.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter. Ensure there are no spelling or grammatical errors, as attention to detail is crucial in this field. A polished application reflects your professionalism.
How to prepare for a job interview at Smartedge Solutions
✨Understand the Regulatory Landscape
Familiarise yourself with the latest regional labelling regulations and guidance. Being able to discuss these in detail will show your expertise and readiness for the role.
✨Showcase Your Experience
Prepare specific examples from your past roles that demonstrate your experience in regulatory affairs and labelling. Highlight any successful projects or challenges you've overcome.
✨Demonstrate Attention to Detail
Since proofreading and gap analysis are key responsibilities, be ready to discuss how you ensure accuracy in your work. You might even want to bring a sample of your previous work to illustrate your process.
✨Communicate Effectively
Excellent communication skills are essential for this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory concepts.
