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For Companies At a Glance
- Tasks: Lead global regulatory submissions and drive innovative technology projects.
- Company: Join a leading life sciences recruiter with a focus on exceptional talent.
- Benefits: Competitive contract role with opportunities for professional growth.
- Why this job: Make a real impact in global compliance and innovation in the life sciences sector.
- Qualifications: BS degree and solid background in Regulatory Operations required.
- Other info: Dynamic, fast-paced environment with strong team collaboration.
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.
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Regulatory Operations Manager employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Operations Manager
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory field on LinkedIn or at industry events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by knowing your stuff! Brush up on the latest regulatory trends and be ready to discuss how your experience aligns with the role. Confidence is key!
✨Tip Number 3
Showcase your skills through real-life examples. When asked about your experience, share specific projects where you managed submissions or improved processes. It’s all about demonstrating your impact!
✨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 are proactive about their job search.
We think you need these skills to ace Regulatory Operations Manager
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 your background makes you a perfect fit for our team. Keep it concise but impactful – we love a good story!
Showcase Your Technical Skills: Since this role requires strong technical skills, be sure to mention your experience with MS Word, eCTD publishing, and any other relevant tools. We’re keen on candidates who can hit the ground running with our existing systems.
Apply Through Our Website: Don’t forget to apply through our website! It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team at StudySmarter!
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 submission processes, especially for FDA and EMA. Being able to discuss these confidently will show that you're not just familiar with the basics but are also ready to tackle complex global regulatory projects.
✨Showcase Your Project Management Skills
Prepare examples of how you've managed submissions or projects in the past. Highlight your planning and organisational skills, and be ready to discuss how you track progress and ensure quality control. This will demonstrate your ability to handle the responsibilities of the role effectively.
✨Communicate Clearly and Effectively
Since this role involves cross-functional communication, practice articulating your thoughts clearly. Think about how you can convey complex information simply and effectively, as this will be crucial when working with various teams and stakeholders.
✨Be Ready for Technical Questions
Expect questions about your technical skills, particularly with MS Word and electronic submission tools. Brush up on formatting documents and using authoring templates, as being proficient in these areas is key to success in this role.
