TRABAJO REGULATORY AFFAIRS ASSOCIATE CLINICAL

Preferred: • background in cro, mah, regulatory consultancy, or global lsp... • expertise in regulatory labelling, ema/fda/hta submission workflows, and language...

You’ll gain exposure to various therapeutic areas and clinical study types, creating an excellent foundation for growth in global clinical operations, regulatory...

They are looking for a clinical affairs program manager europe... as part of the global clinical affairs team, you will be responsible for developing strategies...

Rac (regulatory affairs certification) is a plus... ? experience:3+ years in regulatory affairs within the medical device, pharmaceutical, skincare, or aesthetic...

Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide good clinical practice, pharmacovigilance...

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans our ideal candidate: skills & other requirements...

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans our ideal candidate: skills & other requirements...

Education:* technologic knowledge (phd or master’s degree in molecular biology, biotechnology, pharmacy, biomedicine or similar)* product technical specifications...

clinical research associate iqvia spain is looking for talented and motivated team member to join our sponsor dedicated team as junior cra...

You’ll support regulatory strategies throughout the product lifecycle, from pre-market submissions and product registrations (including change management) to post-market...

Establishment of regulatory strategies... establish the most suitable regulatory strategy for the customer... knowledge in the review of documents required for clinical...

Communicate updates to regulatory staff... 2-3 years in practical international medical device regulatory... our company is founded on a legacy of trusted brands...

Trains investigational site staff as necessary when applicable, supports preparation of regulatory and / or ec submissions participates in mentoring/training of...

Trains investigational site staff as necessary when applicable supports preparation of regulatory and / or ec submissions participates in mentoring/training of new...

· regulatory compliance (change control, post-approval activities, etc... )· interactions with key business partners and regulatory authorities· launch or supply...

clinical trial protocols, investigator’s brochures, clinical study reports, regulatory documents including maintenance of product licenses, registration dossiers...

Job description executive director, clinical trial operations the clinical research director (crd) is the clinical operations lead in a country/cluster and is responsible...

Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports...