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 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 support 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. Communicate new information to colleagues as necessary.
- Assist 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.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
Apply Now:
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