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Regulatory Affairs Specialist II

Waltham, MARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/300846
 

Job Title:  Regulatory Affairs Specialist II

Job Responsibilities

  • Contribute to the development, production and maintenance of the appropriate
    tracking and compliance tools, reports, plans, tasks and activities pertaining to the
    management of the GPE compliance management system.
     
  • Perform investigation of deviations and monitoring of Corrective actions &
    preventive actions (CAPA) relating to non compliance issues and findings and propose appropriate long-term strategies to line management.
     
  • Perform compliance analysis and Contribute to development, production and
    maintenance of adequate reporting methods to the hierarchy to detect and monitor any significant compliance deviations to the company quality standards and/or regulatory requirements
     
  • Track and communicate on compliance
     
  • Ensure tasks and activities are performed according to the work instructions,
    procedures and Policies in place.
     
  • Contributes as an author or a reviewer to GPE Quality Documents
    developed within the Company and relating to compliance monitoring.
     
  • Interface with internal and external stakeholders and ensure that the appropriate
    contact points are established with the other groups (within Quality, Training &
    Compliance or outside) to respond and address gaps or compliance issues that need resolution by team specialists.
     
  • Support Affiliates on compliance matters as required
     
  • Support the conduct of PV audits/regulatory inspections
     
  • Participate to the Development of compliance programs and quality tools to
    enhance GPE global quality and adherence to SOPS and Regulations.
     
  • Escalate issues / problems to management

Education & Qualifications

  • Scientific background: usually baccalaureate +5 years (Pharm D., Health/Life
    science…) with at least two years experience in Pharmacovigilance / Pharmaceutical environment & safety in an international environment.
    In depth understanding of international pharmacovigilance requirements/updates in particular EU/FDA requirements/international guidelines, e.g. ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation
  • An additional degree in pharmaceutical regulatory environment, or in business
    management or in quality management would be much appreciated.
  • Creativity to propose/create/supervise appropriate tools to support business activity
  • Writing quality documents
  • Project/time management/training
  • ?Good understanding of Corporate Pharmacovigilance Duties and Rules in aPharmaceutical Company
  • Good knowledge of business area and interactions with strong regulatory
  • environment and ability to identify and understand proactively the interactions
    necessary for achieving Business Goals and Objectives
  • Ability to identify proactively and anticipate risk of non-compliance in a complex
    enviroment
  • Knowledge of compliance international Regulations and ICH environment foundations
  • Good analytical/judgment capabilities to understand/analyse/synthesize and
    communicate
  • Project Management Abilities
  • Able to manage both time and priority constraints and to manage multiple priorities
    simultaneously
  • Attention to details
  • Take intitiative and autonomous
  •  Able to lead TCs and meetings
  • Computer literacy, work in database(s)
  • Proven ability to work in international environment and cross-functional team, with
    good interpersonal skills assertiveness / team spirit / caching skills
  • Fluent in English
  • Certifications & Licenses: CAPA?

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/300846