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For Companies At a Glance
- Tasks: Manage regulatory submissions and ensure compliance with global marketing authorisations.
- Company: Leading pharmaceutical company focused on innovation and compliance.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Play a crucial role in shaping drug development and regulatory strategy.
- Qualifications: BSc in Pharmacy or related field with 5 years of experience in drug development.
- Other info: Collaborative environment with a focus on continuous learning and improvement.
The predicted salary is between 50000 - 65000 £ per year.
The Regulatory Manager is responsible for managing regulatory submissions and maintaining regulatory documentation to ensure compliance with global marketing authorizations and global clinical trial applications. This role supports cross‑functional teams, contributes to regulatory strategy execution, and ensures regulatory requirements are consistently met across all assigned projects.
Responsibilities
- Maintain eCTD and IMPD documentation, ensuring consistency, accuracy, and continuous regulatory compliance.
- Provide regulatory support for projects to ensure submission of Competent Authority application in line with project goals.
- Support planning, preparation, and maintenance of regulatory documentation in collaboration with subject matter experts.
- Contribute to development and submission of DSURs, PIPs/PSPs, Orphan Drug Designation applications, Fast Track applications, and other regulatory documents.
- Provide regulatory support for expanded access/compassionate use programs (EAPs).
- Support preparation for Regulatory Agency interactions, including scientific advice meetings.
- Review, quality‑check, and approve regulatory updates per internal procedures.
- Maintain regulatory systems, databases, and trackers.
- Participate in project team meetings, providing regulatory guidance.
- Identify regulatory gaps and collaborate to implement solutions.
- Maintain compliance with internal Quality Systems and applicable GxP standards.
- Support QA in preparation for regulatory agency inspections.
- Maintain current knowledge of relevant global legislation and guidance (UK, EU, USA, ICH).
Basic Qualifications
- BSc in Pharmacy, Biological Science, or related field.
- Minimum 5 years pharmaceutical drug development experience, including 2 years in regulatory affairs.
- Experience preparing INDs, CTAs, and marketing applications.
- Knowledge of FDA, EU, MHRA, and ICH regulations and guidelines.
Preferred Qualifications
- Strong problem‑solving skills and ability to implement solutions.
- Experience supporting regulatory interactions and inspections.
- Knowledge of expanded access/compassionate use program requirements.
Expectations & Competencies
- Ability to write, review, and compile regulatory documents including IMPD, IB, eCTD.
- Proficiency with Microsoft Word and Excel.
Regulatory Affairs Manager in Salisbury employer: Scorpion Therapeutics
Contact Detail:
Scorpion Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Salisbury
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulations and compliance standards. We recommend practising common interview questions related to regulatory submissions and documentation to show you’re the right fit for the role.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest using our website to find roles that excite you and match your expertise in regulatory affairs.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the position. We believe this small gesture can help keep you top of mind for hiring managers.
We think you need these skills to ace Regulatory Affairs Manager in Salisbury
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience with regulatory submissions and compliance, and don’t forget to mention any specific projects that align with our needs at StudySmarter.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your background makes you a perfect fit for our team. Be sure to mention your familiarity with global regulations like FDA and ICH.
Showcase Your Problem-Solving Skills: We love candidates who can think on their feet! In your application, share examples of how you've identified regulatory gaps and implemented solutions in past roles. This will show us you have the skills we need.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about what we do at StudySmarter.
How to prepare for a job interview at Scorpion Therapeutics
✨Know Your Regulations
Make sure you brush up on the latest FDA, EU, and ICH regulations. Being able to discuss these confidently will show that you're not just familiar with the basics but are also up-to-date with current guidelines.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed regulatory submissions or supported cross-functional teams. This will help demonstrate your hands-on experience and problem-solving skills.
✨Be Ready for Technical Questions
Expect questions about eCTD documentation and INDs. Practise explaining your approach to maintaining compliance and how you handle regulatory gaps. This will highlight your expertise in the field.
✨Engage with the Interviewers
Don’t hesitate to ask questions about their regulatory processes or recent projects. This shows your genuine interest in the role and helps you gauge if the company’s values align with yours.