Smita Choudhary Email & Phone Number

Hyderabad, In

Hyderabad Area, India

★ Accountable for coordinating, monitoring, and managing operations while maintaining all safety and compliance regulations, and for leading EU Poison centre compliance for all Corteva products.➤ KEY RESULT AREAS● Increased coordination with regulatory leaders, the supply chain, the hazard communication team, and the artworks team for EU Poison Centre regulation-related questions.● Administering regulatory compliance procedures across all organisational tiers and developing SOPs and Work manuals for PCN process execution.● Providing training in compliance practises and procedures and ensuring team adherence to established SOPs for the collection, creation, and submission of dossiers to ECHA.● In charge of updating UFI for corresponding products in SAP and extracting pertinent data for PCN dossiers.● Staying on top of regulatory developments and changes in the regulatory environment, as well as regulatory oversight of our goods and pertinent markets.● Exceptional skills in coordinating quarterly communication talks with EU nation leaders.

★ Coordinating and implementing life cycle and product risk assessments demonstrates proficiency in identifying, assessing, and communicating product safety concerns.➤ KEY RESULT AREAS● Providing regulatory and product stewardship guidance and direction in daily company activities including customer enquiries, hazard communication, product labelling and literature content, claims validation, and product design control.● Analyzing, understanding, advocating, evaluating, and implementing evolving trends and regulations to ensure ongoing product compliance and safety excellence.● Ascertained that, in accordance with the CLP Regulation, information regarding dangerous mixtures is provided to the European Chemicals Agency and official bodies of particular EU Member States.● Extensive experience managing Non-Disclosure Agreements and exchanging confidential information about mixture compositions with suppliers.● Capable of supplying pertinent information for the notification of Eastman products under the Eurasian Economic Union's Technical Regulation (EEA).

★ Supporting regional compliance, hazard communication, chemical reporting, and other regulations and customer requirements pertaining to the ingredients and chemical composition of goods in support of chemical management, safety assessment, stewardship, and product compliance.➤ KEY RESULT AREAS● Extensive expertise in dossier preparation and compilation for chemical submissions under REACh, in IUCLID format, and via REACH-IT.● Proficient in evaluating products for chemical compliance, as well as assisting in the formulation and implementation of measures to address compliance gaps and completing a Data gap analysis of dossiers.● Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and national regulations, perform product hazard classifications and author and create Safety Data Sheets (SDSs).● Effectively implemented the Legal Entity Readiness plan for Corteva's REACH and other chemical regulatory submissions.● Committed actively to the Legal Entity Readiness effort under the direction of the EMEA Chemical Legislation Leader.● Extensive knowledge of SVHC, Heavy Metals, Conflict Minerals, and RoHS regulations.

Hyderabad Area, India

★ Exceptional skills in ensuring that all regulatory documentation is filed in accordance with company protocols and Quality Management Systems (QMS) for work are adhered to.➤ KEY RESULT AREAS● Comprehensive CMC review and evaluation pertaining to the substance of the Common Technical Document (CTD) for regulatory submissions.● Accountable for ANDA regulatory submissions pertaining to the CMC Life-Cycle.● Relationships with regulatory agencies and strategy planning with third-party contract manufacturers.● Coordinated pre-market and post-market activities within the context of a team, and performed quality assurance.● Assisted corporations in US, European, Russian, and Canadian external Audits.● Identify and report potential Root Cause Analysis (RCA) and Corrective Action Report (CAR) for non-conformances in accordance with the quality processes and FDA regulations.● Utilizing SAP, coordinated with a third party regarding test results, communicated with team members, and verified test results were documented according to GLP criteria.

★ Provided analytical help to the method validation and method development teams for the preparation of analytical protocol and procedure documents.➤ KEY RESULT AREAS● Performed routine analyses of completed products and raw materials in accordance with QBD standards and according to design specifications.● Maintained documents according to Good Laboratory Practice (GLP) and updated standard operating procedures (SOPs) during their review period and if regulatory and quality assurance (QA) guidelines changed.● Capable of creating Batch Data Records and Certificates of Analysis for batch release.

Newry

★ Capable of composing validation protocols and reports, as well as coordinating method validation and method development.➤ KEY RESULT AREAS● Proficiency in the Validation of Finished Products and Stability of pharmaceutical batches.● Improved interaction with Regulatory Affairs about the quality control review of paperwork associated with the process validation of pharmaceutical products.

Executive Mba, Organizational Leadership

Master’S Degree, Drug Discovery And Development, Distinction

Master of Science

Bachelor’S Degree, Pharmacy, First Class

B.Pharmacy

Secondary School Certificate

SSC