Pharma - regulatory assistant (syngene)

Roles and Responsibilities

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned

• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards

• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.

• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.

• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self

• Compliance to Syngene’ s quality standards at all times

• Hold self and their teams accountable for the achievement of safety goals

• Govern and Review safety metrics from time to time

Core Purpose of the Role: Support Pharma Regulatory affairs as “Associate” working on the Regulatory Operation activities such as preparation submission and maintenance of regulatory Documentation per GXP requirements.

Role Accountabilities:

• Assist in the preparation of the regulatory applications and submissions to Regulatory Agencies - Test license, Import license, Export license applications.

• Maintain regulatory information database, trackers and documentation systems.

• Ensure all records are updated and stored correctly to support audit readiness and traceability

• Assist in monitoring regulatory changes and updates.

• Work closely with other departments to gather the necessary information for regulatory submissions.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence

• Integrity

• Professionalism

Specific requirements for this role

1. Demonstrated Capability- Learning acumen and hard working

2. Education- Postgraduate in Science / B-Pharma

Skills and Capabilities

1.Good knowledge in the Microsoft office suite :word,excel,power point

2. Problem Solving skills

3.Engage in ongoing learning opportunities