Regulatory Affairs Specialist
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

St Albans Full-Time 28800 - 43200 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Join us as a Regulatory Affairs Specialist and manage the lifecycle of Marketing Authorizations.
  • Company: We're a growing generics pharmaceutical manufacturer focused on compliance and innovation.
  • Benefits: Enjoy a dynamic work environment with opportunities for growth and collaboration.
  • Why this job: Be part of a team that impacts healthcare while developing your regulatory expertise.
  • Qualifications: Bachelor's degree required; 2 years in Regulatory Affairs or related field preferred.
  • Other info: Send your CV to e.smailes@x4lifesciences.com and refer friends for a bonus!

The predicted salary is between 28800 - 43200 £ per year.

Job Title: Regulatory Affairs Officer Please make an application promptly if you are a good match for this role due to high levels of interest. Salary: £40,000 – £45,000 Location: Hertfordshire, UK Job Type: Permanent A growing Pharmaceutical manufacturer are looking to expand their Regulatory team with the addition of a Regulatory Affairs Specialist. They are looking for an individual that is hard working and self- motivated to assist with all things regulatory. Key Responsibilities: Oversee all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs) Assist in the preparation, compilation, and publication of documentation for the Common Technical Document (CTD) dossier. Collaborate with in-house teams, third-party designers, and contract sites to develop and update packaging artwork. Create and maintain patient information leaflets and packaging components, managing artwork to ensure compliance with regulatory standards and company approval systems. Lead and/or assist in submitting licenses and authorizations for new products and modifications to existing products. Experience and Qualifications Required: Bachelors degree required, ideally in sciences, engineering, medical/scientific writing, or public health administration. At least 2 years of experience in Regulatory Affairs or a related field. Proven experience in preparing technical documentation for regulatory submissions. Ability to work independently and manage daily regulatory responsibilities for a product portfolio. How to apply: Apply to e.smailes@x4lifesciences to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.

Regulatory Affairs Specialist employer: X4 Life Sciences

Join a dynamic and innovative generics pharmaceutical manufacturer that values hard work and self-motivation. Our collaborative work culture fosters professional growth, offering opportunities to engage with diverse teams and contribute to meaningful projects in regulatory affairs. Located in a thriving area, we provide competitive benefits and a supportive environment that encourages continuous learning and development.
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Contact Detail:

X4 Life Sciences Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Regulatory Affairs Specialist

✨Tip Number 1

Familiarize yourself with the Common Technical Document (CTD) format, as this is crucial for your role. Understanding the structure and requirements of the CTD will help you stand out during discussions with our team.

✨Tip Number 2

Network with professionals in the Regulatory Affairs field. Attend industry conferences or webinars to connect with others who may have insights into our company and the specific challenges we face in regulatory compliance.

✨Tip Number 3

Brush up on your communication skills, both verbal and written. Being able to effectively communicate with various stakeholders is key in this role, so practice articulating complex regulatory concepts clearly.

✨Tip Number 4

Stay updated on the latest regulations and guidelines in the pharmaceutical industry. This knowledge will not only prepare you for the role but also demonstrate your commitment to staying informed and compliant.

We think you need these skills to ace Regulatory Affairs Specialist

Regulatory Knowledge
Technical Documentation Preparation
Common Technical Document (CTD) Familiarity
Lifecycle Management
Compliance Management
Stakeholder Communication
Packaging Artwork Development
Patient Information Leaflet Creation
Database Management
Regulatory Submissions
Audit Support
Project Management
Attention to Detail
Problem-Solving Skills
Self-Motivation

Some tips for your application 🫡

Tailor Your CV: Make sure to customize your CV to highlight your experience in Regulatory Affairs. Focus on relevant roles and responsibilities that align with the job description, especially your experience with Marketing Authorizations and technical documentation.

Craft a Strong Cover Letter: Write a compelling cover letter that showcases your motivation for the role and your understanding of the regulatory landscape. Mention specific experiences that demonstrate your ability to manage compliance activities and collaborate with various stakeholders.

Highlight Relevant Skills: Emphasize your strong verbal and written communication skills in your application. Provide examples of how you've effectively interacted with regulatory authorities or managed documentation processes in previous roles.

Proofread Your Application: Before submitting your application, thoroughly proofread your CV and cover letter. Ensure there are no grammatical errors and that all information is clear and concise, as attention to detail is crucial in Regulatory Affairs.

How to prepare for a job interview at X4 Life Sciences

✨Showcase Your Regulatory Knowledge

Be prepared to discuss your understanding of regulatory processes, especially regarding Marketing Authorizations and the Common Technical Document. Highlight any specific experiences you have had in preparing technical documentation for submissions.

✨Demonstrate Strong Communication Skills

Since the role requires effective communication with various stakeholders, practice articulating your thoughts clearly. Prepare examples of how you've successfully collaborated with teams or communicated complex information in the past.

✨Highlight Your Attention to Detail

Regulatory Affairs demands precision. Be ready to provide examples of how you've managed compliance activities or maintained regulatory files and databases. This will show your potential employer that you can handle the meticulous nature of the job.

✨Prepare for Scenario-Based Questions

Expect questions that assess your problem-solving skills in real-world situations. Think about challenges you've faced in previous roles related to regulatory affairs and how you overcame them, particularly in audits or during product development.

Regulatory Affairs Specialist
X4 Life Sciences
Apply now
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