CTA Regulatory coordinator in BASEL

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

job details

veröffentlicht
Ort
BASEL, Basel-Stadt
Sektor
Life Sciences
Jobtyp
Temporär
Referenznummer
16593
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: 

Specialist Regulatory affairs - CTA Regulatory coordinator

 

Location:Basel

Contract: Temporary for one year.

You will provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives.

 

Your Responsibilities: 

  • Support regulatory submission to national HAs world-wise as required: e,g, support for putting together dossiers for submission, coordinating operational activities related to M1 (administrative forms filling in; translations coordination; artworks coordination if required etc.)

  • Prepare and/or co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments worldwide.

  • Responsible for managing regulatory Clinical Trial Applications submission activities for allocated clinical trials directly to Health Authorities or facilitating the CTA submission by local personnel in their specific country.

  • Liaise with and provide oversight to CRO supporting the CTA submissions and query management.

  • Accountable for the implementation of the global CTA submission strategy, as well as the quality and extensiveness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.

  • Ensure that the mandatory regulatory requirements are in place to comply with country-specific requirements for CTAs or other regulatory submissions as required.

  • Interact with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the agreed regulatory strategy for development medicinal products

  • Anticipate and bring solutions for potential regulatory risks

  • Maintain good knowledge of regulatory requirements and guidelines especially European regulations on Clinical trials, or other upcoming regulatory initiatives as assigned (e.g. regulations or guidance on novel product initial registration or lifecycle management).

  • Communicate and educate cross-functional teams on European regulatory requirements and changes in the regulatory landscape.

  • Participate in process improvement initiatives within GRS or the International HQ as required

  • Maintain an effective archiving and submissions/approvals tracking records

 

Your profile:

  • Degree in Life Science or related discipline

  • 4+ years of experience in the Pharmaceutical industry.

  • 2+ years of experience in Regulatory

  • Experience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European Union

  • Knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)

  • Detailed regulatory submission experience and regulatory knowledge

  • Proven project management experience and leadership skills

  • Excellent knowledge of English, spoken and written

  • Verified ability to lead multi-functional teams, building strong and productive relationships across an organization.

 

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