Spécialiste des affaires réglementaires

Contracter: Foster City, Californie, États-Unis

Salaire : 40.00 USD par heure

Code du travail: 354691

Date de fin: 2024-11-09

Statut d'emploi: Expiré

Cet emploi n'accepte plus de candidatures
Secteur d'activité : Pharmaceutique
Job Title: Regulatory Affairs Assistant - II
Durée : 6 mois [+ Possibilités de prolongation] 
Emplacement : À distance
Échelle salariale - 35 $ à 40 $/heure 
 
Rôles et responsabilités du poste : 
  • Perform data entry, RIM System to enter relevant information to support key CMC RA stakeholders.
  • Work collaboratively to support the team by executing routine data entry, such as the input of submission related dates, regulatory assessment comments.
  • Ensure completeness, correctness and consistency of data.
  • Responsible for acquisition of required system skills and knowledge; training supported by manager and peers.
  • Work is performed under the general supervision of more senior Regulatory Affairs CMC professionals.
Connaissances et compétences:
  • Doit être familier avec la saisie de données dans des systèmes d'information complexes.
  • Should have experience with Vaults, experience with the RIM Vault.
  • Strong verbal and written communication skills and interpersonal skills.
  • Excellent organizational skills and ability to work on multiple concurrent projects with tight timelines are required.
  • Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
    Scientific background preferred.
  • Biologics experience is a plus

Required Years of Experience: At least 2 – 3 years of experience

  • Top 3 Required Skill Sets: Familiarity with data entry into complex information systems; strong verbal and written communication skills; experience with Vault, including RIM
  • Top 3 Nice to Have Skill Sets: Basic understanding of Regulatory Affairs; scientific background preferred; biologics experience is a plus
  • Unique Selling Point of this role: This role is a great opportunity for someone who is passionate about advancing therapeutics against life-threatening diseases, while working with a collaborative team in Regulatory Affairs.
  • Required Degree or Certification B.S. preferred
Exigence d'emploi
  • CMC
  • JANTE
Contactez un recruteur
  • Recruteur
  • Email
  • Téléphone
  • Shivani Awasthi
  • shivani.awasthi@collabera.com
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