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- Tasks: Lead global regulatory submissions and drive innovative technology projects.
- Company: Proclinical, a top life sciences recruiter with a focus on exceptional talent.
- Benefits: Competitive contract role with opportunities for professional growth in a dynamic environment.
- Why this job: Make a real impact in global compliance and innovation within the life sciences sector.
- Qualifications: BS degree and solid experience in regulatory operations and submissions.
- Other info: Join a fast-paced team and enhance your skills in a supportive atmosphere.
The predicted salary is between 36000 - 60000 £ per year.
Drive global compliance and innovation as our next Regulatory Operations Manager – leading submissions and shaping regulatory technology worldwide. Proclinical is seeking a Regulatory Operations Manager to join our client's team. The successful candidate will be an important member of our Regulatory Team, reporting to the Director, Regulatory Operations, managing submissions for worldwide regulatory filings and driving the implementation of complex global regulatory technology projects.
Summary of Key Responsibilities
- Manages the compilation, publishing, quality control, dispatch and archiving of dossiers through the product lifecycle for assigned projects.
- Represents Regulatory Operations and participates in regulatory project team activities for assigned projects.
- Works independently with project teams to design and execute high‐quality submission plans, ensuring the timelines and technical requirements are mutually understood and in line with Alnylam and Health Authority Standards.
- Performs basic project‐management tasks to build a submission content plan and track and report on the progress of a submission.
- Communicates cross‐functionally to ensure submission documents are received on time and are of high quality.
- Works within the existing regulatory tools and systems (EDMS and eCTD Publishing) and supports filing team members to ensure compliance.
- Creates submission records in the Regulatory Information Management (RIM) System.
- Proactive review and QC of all RIM records (e.g. HAQs, Responses, Commitments, etc.) associated with submissions for assigned programs.
- Interprets regulatory standards, guidances, procedures and regulations to produce regulatory submission business requirements and ensures requirements are implemented. Communicates new information to colleagues as necessary.
- Assists authors on document formatting and submission readiness.
- Participates in any inspection readiness activities for assigned programs.
Qualifications
- BS and a solid background in Regulatory Operations.
- Solid understanding of the regulatory submissions process (including electronic submissions), with experience in filing and document archiving, and strong attention to detail. Expert in global electronic submission requirements (FDA, EMA, and ROW).
- Outstanding technical skills with extensive experience with MS Word and formatting with authoring templates and style guides.
- Effective planning and organizational skills with basic understanding of project‐management concepts.
- Specialist knowledge, analytical skills, broad conceptual and practical experience to solve complex problems. Experience with process design and improvement.
- Strong interpersonal skills, good oral and written communication skills, and a proven ability to contribute to a team‐based, fast‐paced environment are necessary.
- Ability to work with substantial discretion within broad guidelines.
Contact Peter Duvall at p.duvall@proclinical.com for difficulties applying or further questions.
If you are interested in applying to this exciting opportunity, please click 'Apply' or 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
Seniority level: Mid‐Senior level
Employment type: Contract
Job function: Science
Industries: Professional Services
Regulatory Operations Manager in London employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Operations Manager in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory processes. Show them you’re not just another candidate; demonstrate your knowledge about their projects and how you can contribute to their success.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. The more comfortable you are, the better you'll perform when it counts.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step to engage with us directly.
We think you need these skills to ace Regulatory Operations Manager in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Operations Manager role. Highlight your experience with regulatory submissions and any relevant projects you've managed. We want to see how your skills align with 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 affairs and how you can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Technical Skills: Since this role requires strong technical skills, make sure to mention your experience with MS Word, eCTD publishing, and any other relevant tools. We’re keen on seeing how you’ve used these in past roles to drive success.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you don’t miss out on any important updates. Plus, we love seeing applications come through our platform!
How to prepare for a job interview at Proclinical Staffing
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory standards and guidelines, especially those related to FDA, EMA, and ROW submissions. 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 practices.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed submission plans in the past. Highlight your ability to track progress and communicate effectively with cross-functional teams. This will demonstrate your organisational skills and your understanding of project management concepts.
✨Be Ready for Technical Questions
Expect questions about your experience with electronic submissions and regulatory tools like EDMS and eCTD Publishing. Brush up on your technical skills, especially with MS Word formatting and authoring templates, as these are crucial for the role.
✨Demonstrate Team Spirit
Since this role involves working closely with various teams, be prepared to discuss how you've contributed to team success in previous roles. Share specific instances where your interpersonal skills made a difference, showing that you can thrive in a fast-paced, collaborative environment.