ClinChoice

Global CRO providing full-service clinical development

Senior Associate - Regulatory Affairs

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBengaluru, Karnataka, IndiaNo salary listedIn-person

About the Job

Requirements

High technical understanding of regulatory requirements for raw materials across categories including cosmetics, over-the-counter products, drugs, food, and nutrition.
Knowledge of toxicology and safety-assessment information for raw materials across cosmetics, over-the-counter products, drugs, food, and nutrition.
Ability to manage a high volume of requests and manage time and tasks efficiently.
Disciplined execution and attention to detail to evaluate information thoroughly, follow processes, and meet request timelines.
Effective, timely, and proactive communication with internal and external stakeholders, including suppliers.
Ability to understand problems and identify practical, time-bound solutions.
Critical thinking to ask appropriate questions, avoid redundant questions and processes, and apply lessons from past requests.
Sense of urgency and learning agility to understand business impact and immediately apply learning to current and future work.
Ability to work in fast-paced conditions, align quickly, and support faster decision-making.

Responsibilities

Initiate requests within 24 hours of receipt and meet standard turnaround times for all requests.
Understand each request's objective and seek clarification, project background, or missing information as needed before initiation.
Communicate effectively with suppliers, highlight delays in receiving supplier information, and escalate on time.
Update and maintain the Global Request Tracker in a timely manner, using it as the single global reference for each request throughout its lifecycle in raw-material data management.
Communicate promptly, effectively, and transparently with global stakeholders about all requests.
Collaborate with toxicology partners to learn and adapt quickly to supplier information requirements for specific requests.
Maintain right-first-time information collection and validate high volumes of incoming data across requests.
Understand end-to-end data connectivity across systems and maintain data accuracy when entering information into systems.
Complete requests right-first-time and on time within turnaround targets.
Consistently meet quality and productivity key performance indicators.

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 –

Complete all requests, right-first time & on-time (within TAT)
Ensure to meet the KPIs on quality & productivity consistently

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

About the Company

ClinChoice

Global CRO providing full-service clinical development

ClinChoice is a global contract research organization (CRO) that provides outsourced clinical development services across the full lifecycle for pharmaceutical, biotechnology, medical device, and consumer health customers. It delivers services such as clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance to support trials from early development through post-approval. The company differentiates itself with a large, global workforce—over 4,000 professionals in more than 30 countries—and growth through mergers and acquisitions, enabling multinational trial execution. Its goal is to help clients accelerate approvals and navigate complex regulatory environments by offering flexible project-based and FSP engagement models for end-to-end development and lifecycle support.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Whitemarsh Township, Pennsylvania
Founded: 1995

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