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Regulatory Affairs Assistant

Bengaluru, KarnatakaPosted 1 weeks ago
Full-timeonsiteentry

Job Description

Regulatory Affairs Assistant

  • Full-time

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Join our international team and support regulatory aspects of clinical research projects. You'll help streamline communication, manage documents, and maintain key systems - all while learning from experienced regulatory professionals.

Office-Based in Bangalore, India

What You'll Do:

  • Communicate with project teams on regulatory matters and serve as a support contact for PSI services
  • Maintain departmental tracking systems and regulatory calendars
  • Support the preparation of regulatory submissions and license applications under supervision
  • Perform quality control on outbound documents and manage filing with Document Management Systems
  • Translate regulatory documents as needed
  • Provide technical assistance with regulatory feasibility research
  • Train PSI staff on departmental software and provide administrative support to the Regulatory Affairs team

Qualifications

  • College/University degree or an equivalent combination of education, training & experience
  • Life Science degree is a plus
  • Prior experience in Clinical Research
  • Common European Framework of Reference for Language (CEFR) B2 level in English.
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication and collaboration skills

Additional Information

What we offer:

  • We value your time so the recruitment process is as quick as 2-3 meetings
  • We'll prepare you to do your job at highest quality level with our extensive onboarding program
  • You'll have permanent work agreement at a stable, privately owned company
  • We're constantly growing which means opportunities for personal and professional growth

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

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Regulatory Affairs Assistant at PSI CRO | Renata