Team member, Regulatory Affairs

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 companys 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 Syngenes 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.
The candidate will combine his/her knowledge of scientific regulatory guidelines, CMC regulatory and filing skills to ensure successful filing, registrations, and post-approval maintenance for the intended countries.
The candidate will lead eCTD filing, Regulatory DMS and QMS system activities..
Role Accountabilities.
The candidates contribution will help bring the much-needed therapeutics to the unmet need of the patients, thereby positively impacting mankind.
The candidate will be accountable for:.
Pivotal CMC Regulatory support throughout the development cycle of the novel drugs space and generics space, including small molecule biologics, in marketing authorization / DMF filing and lifecycle management, predominantly for Developed countries and for certain Emerging countries, based on the market requirement..
Research on regulatory requirements for new molecules / category of products based on business need in time-bound manner and provide feasibility/technical inputs to the team..
Identify requirements for IND, NDA, MAA, ANDA, ANADA and other Dossiers, prepare checklists, ensuring regulatory compliance..
Interact with stakeholders, collate necessary document, Review plant and RD documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc, conduct thorough regulatory assessment, identify risks, communicate to team and client, and recommend corrective measures..
Plan and develop sections, compile, author, and Publish eCTD Dossiers.
Ensure timely submission.
Respond to regulatory agencies on a timely basis.
Responsible for Regulatory project management..
Provide Regulatory strategy inputs to the team and the clients.
Assessing the regulatory requirements for various business requirements as and when needed..
Maintain all regulatory filings, Product Marketing authorization renewals to ensure continuous validity.
Maintain, and update product dossiers/DMFs as required to meet changes in internal systems, changes in regulatory guidelines..
Maintain Quality Agreement Tracker, prepare Quality Agreement Checklists, and review New Quality Agreements..
Train staff in regulatory policies or procedures.
Develop and maintain standard operating procedures or local working practices..
Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety..
Attend training on environment, health, and safety (EHS) measures imparted by the company..
Traveling to other sites within Karnataka if necessary, though travel requirements are minimal..
Leadership Capabilities.
Syngene Values.
All employees will consistently demonstrate alignment with our core values.
Excellence.
Integrity.
Professionalism.
Specific Requirements For This Role.
Experience.
Demonstrated Capability