Regulatory Affairs Cta Coordinator

vor 1 Tag


Schweiz NonStop Consulting Vollzeit

We are currently hiring for a Regulatory Affairs CTA Coordinator, temporary assignment, to join a top biopharmaceutical enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.

**Activities**:
Support regulatory submission of CTAs to national HAs world-wide as required: e,g, support to putting together dossiers for submission, coordinating operational activities related to M1 (administrative forms filling in; translations coordination; artworks coordination if required etc.)
Co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments worldwide.
Supports the 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.
Supports 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.
Supports 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
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 life0cycle 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

**Experience**:
Degree in Life Science or related discipline
3+ years of experience in the Pharmaceutical industry.
2+ years of experience in Regulatory
Knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)
Regulatory submission experience and regulatory knowledge
Project management experience and leadership skills
**Location**: Switzerland
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.



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