Submissions Manager, Regulatory Operations in BASEL

veröffentlicht
Kontakt
Lucie Nasshan, Basel Professionals Health Care & Life Sciences
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
BASEL, Basel-Stadt
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
15772
Kontakt
Lucie Nasshan, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50

Stellenbeschreibung

Do you wish to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative ?

For our client, this pioneering biotechnology company, we are looking for a: 

Submissions Manager, Regulatory Operations  

 

Location:Basel

Contract: Temporary for one year.

The Regulatory Operations Submission Manager is responsible for the planning, managing and tracking of regulatory submissions. In collaboration with the Regulatory Lead, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner.  

 

Your Responsibilities: 

  • Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC.

  • As a global submissions’ expert, ensure the project team has awareness and knowledge of e-submissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.

  • Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.

  • Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (BLA, MAA, Variations, etc.), updates, amendments, and variations to global regulatory agencies.

  • Manage activities of the publishing vendors in preparation of high-quality submission packages and their timely delivery to health agencies.

  • Maintain technical expertise of regulatory requirements and ensures alignment with company processes and client requirements

  • Act as a subject matter expert for document management system.

  • Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes. Manage submission and product life-cycle information.

  • Lead and manage special projects as needed

 

Your profile:

  • Bachelor’s degree in a scientific discipline or systems technology or equivalent

  • 5-8 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)

  • Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools

  • Extensive knowledge of European, EEA, Western Europe, US, and ROW electronic submission standards and industry trends for electronic submission requirements.

  • Knowledge of SPOR, and IDMP requirements.

  • A demonstrated ability to lead and/or collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)

  • Excellent document formatting/troubleshooting skills in MS Word/PDF Professional

  • Excellent English Language Skills.

You would like to contribute to a fast-thinking and innovative company, changing the industry ? Apply now

Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position