Senior Associate - Regulatory Affairs

ClinChoice · Bengaluru

Roles & Responsibilities

End to end request governance for raw material data management -

On-time initiation (within 24h of request receipt), adherence to the standard turnaround time (TAT) for all requests
Understand the objective of the request. If needed, seek clarification/project background/missing information for initiating the request
Handling supplier communication effectively, highlighting delays in getting supplier information & on-time escalation
Timely update & maintenance of the Global Request Tracker (GTR) – GTR must be utilized as the single global source of reference for the entire lifecycle of each request within RM data management
Timely, effective and transparent communication with global stakeholders for all requests

Technical expertise -

High standard of technical understanding of regulatory requirements for raw materials within all categories of use (Cosmetics, OTC, Drugs, Food/Nutritional’s etc.)
Knowledge of toxicology & safety assessment related information for raw materials within all categories of use (Cosmetics, OTC, Drugs, Food/Nutritional’s etc.). Maintain a strong collaboration with the Toxicology partners to learn & quickly adapt for information requirement from suppliers as per specific request needs
Data varsity – right first-time information collection & validity of the high volumes of data incoming for all requests should be maintained
Understand the end-to-end data connectivity across all systems & maintain high standard of data accuracy at the time of data entry in the systems

Sustain an Ownership Mindset –

Soft skills required (must have) -

Project/ Request management – Given the huge number of requests that flow in this project, efficiency in overall & individual request, time & task management is highly required
Disciplined execution & ability to provide attention to detail – Should be fully focused and evaluate the information thoroughly and follow the process in disciplined way to ensure on time visibility to the stakeholders and flawless execution to meet the individual request timelines.
Communication skills – Effective, timely and proactive communication with all internal & external (suppliers) stakeholders
Problem solving – Understand the criticality of the problem & seek practical, time-bound solutions to overcome the challenge
Critical thinking – Asking right questions, avoidance of redundant questions, steps, processes & learning from past experiences to extrapolate the lessons to other requests
Sense of urgency & learning Agility – Understand the urgency and its impact to the business. Apply the learnings immediately in the ongoing and future projects/work.
Agility & Resilience – ability to work under fast paced conditions, taking quick alignments for faster decision making