Senior Regulatory Writer

Senior Regulatory Writer

Wakefield Full-Time 43200 - 72000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Create high-quality regulatory documents and mentor junior writers in a collaborative environment.
  • Company: Join a leading firm dedicated to delivering exceptional regulatory writing services.
  • Benefits: Enjoy unlimited holiday, flexible hours, healthcare, and extensive training opportunities.
  • Why this job: Be a key player in impactful projects while developing your skills and expertise.
  • Qualifications: BSc, MSc, or PhD in life sciences; proven regulatory writing experience required.
  • Other info: Remote work with a supportive team culture and opportunities for professional growth.

The predicted salary is between 43200 - 72000 £ per year.

Independently produce high-quality core regulatory documents that meet or exceed expectations, delivered on time and within budget. Provide value to clients, colleagues, and the wider business through proactive contributions. Take ownership of key regulatory writing deliverables with autonomy, ensuring clarity, accuracy, and objectivity. Recognized as a subject matter expert and primary point of contact across multiple document types and projects. Mentor and guide junior writers, delegate appropriately, and contribute to a collaborative team environment.

KEY RESPONSIBILITIES

  • Lead the development of regulatory documents that are scientifically sound and aligned with submission goals.
  • Provide project-level guidance to team members, including client-specific expectations and document strategies.
  • Critically evaluate client-supplied materials and clinical data to produce compliant, well-written outputs.
  • Advise clients and colleagues based on knowledge of regulatory requirements and submission strategy.
  • Manage source materials, version control, and filing in accordance with established SOPs.
  • Perform document reviews and data quality checks; support or lead QC efforts across deliverables.
  • Lead or contribute to project kickoffs, timelines, and resource planning.

Team Collaboration

  • Actively support and collaborate with colleagues across writing projects.
  • Delegate document components or tasks to less experienced writers when appropriate.
  • Share knowledge through mentoring, peer review, and best-practice discussions.

Client Service & Relationship Management

  • Serve as a confident, knowledgeable contact for clients.
  • Facilitate productive client meetings and resolve project issues collaboratively.
  • Build trust through reliable, high-quality delivery and strategic insight.

Project & Financial Management

  • Monitor project scope and cost against budget; escalate or negotiate amendments as necessary.
  • Align deliverables to contractual obligations and track effort for billing purposes.
  • Support commercial awareness through accurate time reporting and schedule management.

Business Development (as applicable)

  • Contribute to relationship-building with new and existing clients.
  • Support identification of new project opportunities or extensions.

QUALIFICATIONS

  • BSc, MSc, or PhD in a life sciences or medically related field (required).
  • Proven experience as a lead author on multiple regulatory documents, including at least 3 of the following: protocols, clinical study reports, clinical summaries, clinical overviews, investigator brochures, narratives, briefing documents, or regulatory response documents.
  • Experience leading projects and managing client relationships in a regulatory writing context.

SKILLS & COMPETENCIES

  • Deep understanding of regulatory requirements for core documents (e.g., ICH guidelines, CTD structure).
  • Ability to lead writing activities with minimal oversight, especially for clinical regulatory documents.
  • Skilled in document strategy, content planning, and scientific interpretation.
  • Strong project management and organizational skills.
  • Confident communicator with strong interpersonal abilities.
  • Proficient in reviewing peer documents and providing constructive feedback.
  • Adept at managing multiple projects and timelines concurrently.
  • Demonstrates leadership qualities and fosters development of junior team members.
  • Committed to continuous learning and personal development.

BENEFITS

  • Unlimited Holiday Policy (including office closure between Christmas and New Years)
  • Open to part-time work
  • Bonus scheme
  • Healthcare
  • Pension
  • Flexible working hours
  • Extensive training development
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Contact Detail:

Meet Life Sciences Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Senior Regulatory Writer

✨Tip Number 1

Familiarise yourself with the latest ICH guidelines and CTD structure, as these are crucial for a Senior Regulatory Writer role. Being well-versed in these regulations will not only boost your confidence but also demonstrate your expertise during interviews.

✨Tip Number 2

Showcase your leadership skills by preparing examples of how you've successfully mentored junior writers or led projects in the past. This will highlight your ability to take ownership and guide others, which is essential for this position.

✨Tip Number 3

Network with professionals in the regulatory writing field through platforms like LinkedIn. Engaging with industry groups can provide insights into current trends and may even lead to referrals for open positions at StudySmarter.

✨Tip Number 4

Prepare to discuss specific regulatory documents you've authored, focusing on the challenges you faced and how you overcame them. This will demonstrate your problem-solving skills and your ability to deliver high-quality work under pressure.

We think you need these skills to ace Senior Regulatory Writer

Regulatory Writing
Scientific Interpretation
Project Management
Document Strategy
Client Relationship Management
Attention to Detail
Version Control
Quality Control
Mentoring and Coaching
Interpersonal Communication
Time Management
Knowledge of ICH Guidelines
Critical Evaluation of Clinical Data
Team Collaboration
Continuous Learning

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in regulatory writing, especially any lead author roles on core documents. Use specific examples that demonstrate your understanding of regulatory requirements and project management skills.

Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory writing and how your background aligns with the job description. Mention your experience mentoring junior writers and your ability to manage client relationships effectively.

Showcase Your Expertise: When detailing your experience, focus on your subject matter expertise in regulatory documents. Highlight specific projects where you led the development of documents like clinical study reports or investigator brochures.

Proofread and Edit: Before submitting your application, thoroughly proofread all documents. Ensure clarity, accuracy, and professionalism in your writing, as this reflects your attention to detail and commitment to high-quality deliverables.

How to prepare for a job interview at Meet Life Sciences

✨Showcase Your Regulatory Expertise

Make sure to highlight your experience with regulatory documents during the interview. Be prepared to discuss specific projects you've led, the types of documents you've authored, and how you ensured compliance with regulatory requirements.

✨Demonstrate Leadership Skills

Since the role involves mentoring junior writers, share examples of how you've guided team members in the past. Discuss your approach to delegation and how you foster a collaborative environment within your team.

✨Prepare for Client Interaction Scenarios

As client service is key, think of instances where you've successfully managed client relationships. Be ready to explain how you facilitated meetings, resolved issues, and built trust through your work.

✨Discuss Project Management Experience

The role requires strong project management skills, so be prepared to talk about how you've managed timelines, budgets, and resources in previous roles. Highlight any tools or strategies you use to keep projects on track.

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