Kinapse M Pharma Scientist

Kinapse M Pharma Scientist Job Opening Available – Apply Online

Kinapse M Pharma Scientist Job Opening Available – Apply Online. Syneos Health (Kinapse) invites pharma candidates for the Research Job Opening. A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values-driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge.

Job Title: Senior Scientist, Non-Clinical Regulatory

Updated: April 8, 2021

Location: Gurgaon, HR, India

Job ID: 131848

An opportunity has arisen for a Senior Consultant (CMC Regulatory Affairs) to be based in Gurgaon or Bangalore.

Responsibilities

  1. Project Delivery
  • Manages non-clinical project deliverables and submission content in line with project plan
  • Proactively identifies moderately complex issues and risks to project delivery in own work or work of the team and escalates appropriately with associated resolution proposals
  • Undertakes project specific activities independently and within cost and time estimates
  • Responsible for process implementation and ensure process compliance .
  • May support the Manager or Senior Manager in delivery and/or the successful initiation, execution and completion of non-clinical regulatory services for Kinapse’ Global clients
  • May be responsible for reviewing submission output from team members.
  • May assist in work allocation, compilation, tracking and reporting of the project reports on timely basis
  • Applies negotiation skills to recommend time lines and change in requirements
  • As applicable, author non clinical regulatory documents which meet agreed quality standard as agreed with client within stipulated time and cost.
  • Should be acquainted with detail of various regulatory agency’s non-clinical safety requirements and GLP/GXP regulations.
  • As applicable, author and review the protocols and study reports as well as other essential documents required in non-clinical studies.
  • As applicable, author and review non-clinical packages for submission to Health Authorities.
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2. Problem Solving and Analysis

  • Exhibits a growing awareness of project strategy and thinking capability alongside independence
  • Reviews and provides solutions for issues relating to project delivery or escalates appropriately to the Team Leader/Program Leader/Program Director as required

3. People Development

  • May be involved in people development in partnership with PDG leads
  • Provide training and mentoring of team members depending upon the project requirement

4. Training Compliance

Ensure that all training (Kinapse internal training and client training) are successfully completed in a timely manner

Job Requirements

  • Post Graduate with Masters in Pharmacy
  • Experience in non-clinical regulatory affairs with exposure to regulatory filings as a part of a pharmaceutical or generic company is preferred
  • Understanding of toxicological studies required to support clinical trials including genetic and general toxicology studies and nomenclature
  • Knowledge of non-clinical regulatory requirements and/or guidelines (ICH, GCP) and exposure to relevant document management systems is preferred.
  • Good oral / written communication skills
  • Working knowledge of basic office applications, e.g. MS Word/ PowerPoint/ Excel, will be required.

Apply Online

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