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- Tasks: Join us as a Regulatory Affairs Executive and manage vital applications to ensure compliance.
- Company: Be part of a dynamic team in Berkshire, specializing in solid dosage generic pharmaceuticals.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Make an impact in the pharmaceutical industry while working on diverse regulatory projects.
- Qualifications: Ideal candidates should have a strong understanding of regulatory processes and excellent communication skills.
- Other info: This role offers a chance to interface with regulatory authorities and enhance your expertise.
The predicted salary is between 36000 - 60000 £ per year.
An excellent opportunity has arisen for a Regulatory Affairs Executive to join my client based in Berkshire and focusing on cGMP, solid dosage generic pharmaceuticals. Responsibilities: Prepare and submit applications of reliable quality in a timely manner to MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications. Have a good understanding of and be able to execute activities related to the following key areas; Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions. Reclassification of Medicines. Re-baseline / Remediation dossiers. License Transfers (giving away and bringing in) including the due diligence of dossiers. Maintenance of Marketing Authorisations including renewals. Deficiency responses to authorities. Partake in the interfacing with regulatory authorities to facilitate the approval of submissions. Act as a point of contact for other business units, customers, and internal/external teams. Stay informed about new and changing regulatory requirements and ensuri…
Regulatory Affairs Executive employer: Select OH Careers
Contact Detail:
Select OH Careers Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Executive
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements of the MHRA and the National Procedure. Understanding the nuances of these regulations will not only help you in your role but also demonstrate your commitment to the position during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with cGMP and solid dosage generic pharmaceuticals. Engaging with industry experts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in pharmaceutical regulations. Subscribing to relevant newsletters or joining professional organizations can keep you informed and show your proactive approach to potential employers.
✨Tip Number 4
Prepare to discuss specific examples of how you've successfully managed regulatory submissions or interacted with regulatory authorities in past roles. Concrete examples will help you stand out and illustrate your expertise during the interview process.
We think you need these skills to ace Regulatory Affairs Executive
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Executive position. Highlight key responsibilities and required skills, as this will help you tailor your application.
Tailor Your CV: Customize your CV to reflect your experience in regulatory affairs, particularly with cGMP and solid dosage generic pharmaceuticals. Emphasize relevant projects or roles that demonstrate your ability to prepare and submit applications to regulatory bodies like MHRA.
Craft a Strong Cover Letter: Write a compelling cover letter that outlines your understanding of the regulatory landscape and your experience with variations, license transfers, and marketing authorizations. Make sure to express your enthusiasm for the role and how you can contribute to the company.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Select OH Careers
✨Know Your Regulatory Framework
Make sure you have a solid understanding of the regulatory landscape, especially regarding MHRA submissions. Familiarize yourself with the types of variations and licensing processes mentioned in the job description.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world regulatory scenarios. Be ready to discuss how you would handle specific situations related to license transfers or deficiency responses.
✨Showcase Your Communication Skills
As a point of contact for various teams, effective communication is key. Prepare examples that demonstrate your ability to interface with regulatory authorities and collaborate with internal and external stakeholders.
✨Stay Updated on Regulatory Changes
Demonstrate your commitment to staying informed about new regulations and guidelines. Mention any recent changes in the regulatory environment that could impact the pharmaceutical industry, showing your proactive approach.
