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Senior Associate - Regulatory Affairs

ClinChoice
NewPosted today

LOCATION

Bengaluru · Onsite

EXPERIENCE

Not specified

SKILLS REQUIRED

Regulatory ComplianceData GovernanceToxicologyProject ManagementStakeholder Management

Job description

Overview

Senior Associate in Regulatory Affairs responsible for end-to-end request governance of raw material data management across Cosmetics, OTC, Drugs and Food/Nutritionals.

What you'll do

  • Initiate requests on time, within 24 hours of receipt, and meet the standard turnaround time (TAT) for all requests.
  • Understand the objective of each request and seek clarification, project background or missing information where needed.
  • Handle supplier communication effectively, highlight delays in getting supplier information and escalate on time.
  • Update and maintain the Global Request Tracker (GTR) as the single global source of reference for the full lifecycle of each request.
  • Communicate timely, effectively and transparently with global stakeholders on all requests.
  • Collaborate with Toxicology partners to learn and adapt to information requirements from suppliers per request needs.
  • Maintain right-first-time information collection and validity of high volumes of incoming data.
  • Understand end-to-end data connectivity across systems and maintain high data accuracy at data entry.
  • Complete all requests right first time and on time (within TAT), and meet quality and productivity KPIs consistently.

What you'll need

  • High standard of technical understanding of regulatory requirements for raw materials within all categories of use (Cosmetics, OTC, Drugs, Food/Nutritionals etc.).
  • Knowledge of toxicology and safety assessment related information for raw materials within all categories of use.
  • Project/request management: efficiency in overall and individual request, time and task management.
  • Disciplined execution and attention to detail.
  • Communication skills: effective, timely and proactive communication with internal and external (supplier) stakeholders.
  • Problem solving: understand the criticality of a problem and seek practical, time-bound solutions.
  • Critical thinking: ask the right questions, avoid redundant questions and steps, and apply lessons from past experiences to other requests.
  • Sense of urgency and learning agility: understand urgency and business impact, and apply learnings immediately.
  • Agility and resilience: ability to work under fast-paced conditions and make quick alignments for faster decisions.

Details

  • Location: Bengaluru, Karnataka, India.

Read the full description and apply on the company’s own careers page.

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Senior Associate - Regulatory Affairs