Job Description

JOB DESCRIPTIONJob Title: Pharma Regulatory - AssistantRporting Grade: Level 7 IJob Grade: Associate -Team LeaseAbout Syngene : Syngene ( ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spiritMandatory 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 : Assist to the regulatory team in the preparation ,submission and maintenance of regulatory Documents and TrackersRole Accountabilities:

• Assist in the preparation of the regulatory application submissions - Test license applications ,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 ValuesAll employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role * Experience- Fresher /1-2 years

• Demonstrated Capability- learning acumen and hard working
• Education- Postgraduate in Science / B-Pharma

Skills and Capabilities1.Good knowledge in the Microsoft office suite :word,excel,power point2. Problem Solving skills3.Engage in ongoing learning opportunitiesEqual Opportunity Employer:It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodation for qualified individuals with disabilities.

Syngene International