Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead the preparation and delivery of electronic regulatory submissions globally.
- Company: Proclinical, a leading life sciences recruiter with a global impact.
- Benefits: Remote work flexibility, competitive salary, and opportunities for professional growth.
- Other info: Join a dynamic team with excellent career advancement opportunities.
- Why this job: Shape powerful strategies and make a difference in global health regulations.
- Qualifications: Bachelor's degree in life sciences; expertise in regulatory operations required.
The predicted salary is between 36000 - 60000 £ per year.
Work from anywhere and shape powerful strategies that drive results! Enjoy the freedom of remote work while making a global impact with this position in Regulatory Operations.
Proclinical is seeking a Regulatory Operations Consultant to oversee the preparation, publishing, and delivery of electronic regulatory submissions to global health authorities. This role focuses on ensuring compliance with technical, regulatory, and procedural requirements to support marketing authorizations, clinical trial applications, and lifecycle management activities across various markets.
Responsibilities:
- Lead the assembly, publishing, and quality control of electronic submissions (eCTD and NeeS) in line with regional authority requirements.
- Plan and manage submission timelines to ensure timely delivery to health authorities, coordinating with global regulatory teams.
- Ensure technical compliance through proper document formatting, hyperlinking, bookmarking, and metadata accuracy.
- Manage electronic submission gateways and portals, including FDA ESG, EMA CESP, MHRA Submissions Portal, and ANVISA systems.
- Act as the primary operational contact for submission publishing, addressing technical and formatting issues.
- Conduct pre-publishing assessments to ensure submission readiness and consistency across modules.
- Perform final validation and lifecycle maintenance of submissions, ensuring correct sequence management and submission integrity.
- Stay updated on ICH and regional eCTD specifications, implementing changes in publishing practices as needed.
- Collaborate with cross-functional teams to define submission structure, content placement, and publishing strategy.
- Maintain internal submission tracking systems, ensure complete and compliant submission archives, and support audits or inspections.
Key Skills and Requirements:
- Bachelor\’s degree in life sciences, information management, or a related field; advanced degree preferred.
- Expertise in regulatory operations, particularly eCTD publishing and global submission delivery.
- Proficiency in compiling and submitting regulatory dossiers to EMA, FDA, MHRA, and ANVISA.
- Familiarity with submission publishing tools such as Veeva, Lorenz docuBridge, EXTEDO eCTDmanager, or similar systems.
- Strong understanding of regional publishing requirements and sequence lifecycle management.
- Exceptional attention to detail, organizational skills, and problem-solving abilities.
- Effective communication and teamwork skills in global and cross-functional environments.
- Fluency in written and spoken English; additional language proficiency (e.g., Portuguese, Spanish) is a plus.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click \’Apply\’ or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you\’ve read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.proclinical.com/privacy-policy.
Locations
Senior Regulatory Operations Consultant employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Operations Consultant
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory operations field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a job that’s perfect for you!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of eCTD publishing and global submission delivery. We recommend practising common interview questions and scenarios related to regulatory operations to show off your expertise.
✨Tip Number 3
Don’t forget to showcase your attention to detail! During interviews, share examples of how you've ensured compliance and accuracy in past submissions. This will highlight your fit for the role and impress potential employers.
✨Tip Number 4
Apply through our website for a smoother process! It’s the best way to ensure your application gets noticed. Plus, you can easily track your application status and get updates directly from us.
We think you need these skills to ace Senior Regulatory Operations Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Operations Consultant role. Highlight your experience with eCTD publishing and global submissions, as well as any relevant tools you've used. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory operations and how you can contribute to our team. Be sure to mention any specific experiences that relate to the job description.
Showcase Your Attention to Detail: In regulatory operations, attention to detail is key. When submitting your application, double-check for any typos or formatting issues. We appreciate candidates who take the time to ensure their application is polished and professional.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of success. It’s straightforward and ensures your application gets to the right place. Plus, you can easily track your application status!
How to prepare for a job interview at Proclinical Staffing
✨Know Your Regulatory Stuff
Make sure you brush up on the latest ICH and regional eCTD specifications. Being able to discuss these in detail will show that you're not just familiar with the basics, but that you’re genuinely invested in staying updated with industry standards.
✨Showcase Your Tech Savvy
Familiarise yourself with submission publishing tools like Veeva or Lorenz docuBridge. Be ready to share specific examples of how you've used these tools in past roles, as this will demonstrate your hands-on experience and technical expertise.
✨Plan for Timelines
Prepare to discuss how you manage submission timelines and coordinate with global teams. Bring examples of how you’ve successfully navigated tight deadlines in the past, as this will highlight your organisational skills and ability to work under pressure.
✨Communicate Clearly
Effective communication is key in this role. Practice articulating complex regulatory concepts in a straightforward manner. This will not only help you during the interview but also show that you can collaborate effectively with cross-functional teams.