Regulatory Operations Manager

Proclinical Staffing; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading life sciences recruiter in the UK is seeking a Regulatory Operations Manager to drive global compliance and spearhead regulatory submissions. This mid-senior level role involves managing the compilation and quality of submission documents, interpreting regulatory standards, and ensuring compliance within various regulatory frameworks. Candidates require a BS degree and a robust background in regulatory operations, with outstanding skills in project management and electronic submission processes. Proclinical is acting as an Employment Agency for this vacancy.

Qualifications

• Solid understanding of regulatory submissions including electronic submissions.
• Expert in electronic submission requirements (FDA, EMA, ROW).
• Strong attention to detail and communication skills.

Responsibilities

• Manage document quality control and archiving throughout the product lifecycle.
• Facilitate submission timelines and ensure mutual understanding with project teams.
• Conduct proactive review and QC of all RIM records associated with submissions.

Skills

Regulatory submissions process

MS Word formatting

Project management concepts

Analytical skills

Interpersonal skills

Education

BS in a relevant field

Tools

Regulatory Information Management (RIM) System

EDMS

eCTD Publishing

Job description

Director Regulatory Affairs Contract - UK & EU

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 [e-mail] for difficulties applying or further questions.

Apply Now

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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Seniority level

Mid‑Senior level

Employment type

Contract

Job function

Science

Industries

Professional Services