Senior Regulatory Operations Associate

vor 1 Woche

Frankfurt am Main, Deutschland Proclinical Vollzeit

Proclinical are recruiting a Senior Regulatory Operations Associate for a pharmaceutical establishment. This role is on a permanent basis with the ability to work remotely from anywhere in Germany. The client is focused on clinical research and the development of new products.

**Responsibilities**:

- Accountable for gathering, QC, validating, filing and tracking of paper and electronic proposals.
- Offer regulatory publishing and proposal assistance.
- Guarantee allocated proposals are made with quality and in a timely manner.
- You will serve as a main point of contact while organising regulatory publishing actions for all R&D functions.
- Mediate with the company for arranging and publishing CMC-connected content.
- Offer regulatory publishing assistance for other divisions.
- Support the development of allocated regulatory operations initiatives and work instructions.
- Form and create cooperative relations with co-workers.
- Other duties may be assigned to this role.

**Skills & Requirements**:

- Educated to a degree level or corresponding work experience.
- Know-how of FDA/EMA/HC/Swiss Medic guidelines and management for electronic and paper proposals.
- Know-how and familiarity with regulatory operations which involves, formatting, publishing, submitting, life cycling, and filing (eCTD) sequences.
- Exhibited performance in handling and generating time-intensive deliverables.
- Know-how of document management systems and publishing tools such as DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox.
- Computer literacy in Microsoft Office Suite such as Excel, PowerPoint, Word, Access, Visio, etc., as well as SharePoint.
- Familiarity with NDAs/MAAs.
- Project development skills.
- Communication skills both verbally and in writing.
- Able to resolve multifaceted issues.
- Works well with others.
- Project management familiarity.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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