Saritha Devi Email & Phone Number

Telangana, India

Test license applications and clinical trial application, marketing Authorization application to CDSCO for vaccines, VQPD submissions to WHO, Change control assessment and Variation submissions to WHO and CDSCO, Dossiers for vaccine products for international registration, WHO GMP application for vaccines. Regulatory strategy development.

Hyderabad, Telangana, India

Project lead for CTD preparation projects for anti cancer small molecule parenterals and Oral solid dosage forms for International expansions in MHRA through National procedures, European countries through DCP procedure, South Korea, South Africa, GCC, ASEAN countries such as Malaysia, Vietnam, CIS countries such as Russia, Ukraine, EAEU, Belarus and LATAM markets such as Chile, Colombia, Mexico, Peru, which involves below key activities:Creation of CTD templates from scratch based on CTD guidelines and time to time updation based on queries.Development of Submission Strategy for the project taken up.Guiding the project RA team in Sections framing from available dataAssessing the team work and providing time to time feedback and encouraging and self growth and enhanced contribution to organization.Gap Assessment of the available data and communicating the gaps identified to functional teams for filling them for fruitful submission. Preparation and review of DP sections and DS sections for accomplishment of Submission as per the timeline.Identification of issues and risks underlying the project and strategy development with different options for resolving them, by bringing the functional teams in to agreement with the feasible option.Responding the Queries raised by International regulatory authorities and fulfillment of commitments for achieving the targeted approvals and further license maintenance. Responsible for below post- marketing activities: Product Life cycle maintenance:Regulatory impact assessment of change controls for all the registered products. Submission strategy development of changes notification i.e. Type IA, Type IB, Type II B in the registered countries.Submission of Variations to ROW countries. Responding the questions raised by regulatory agencies in Europe, MHRA, ROW marketsSubmission of Annual reports to regulatory agencies.

Hyderābād Area, India

Regulatory Affairs activities: •Renewal of Mfg. license for next five years vide online application by responding to queries given by DCA.• Preparation for Sch M and L audit and response for further approval. • Laisioning of DCA when ever required for Certificates and other approvals. • Site registration documents for Ethiopia registration.• Worked for responding for Ireland queries for API and Prepared API DMF open part.Quality Control:• Trained and Implemented SOPs for Basic QC, Coordinated for repair of old QC instruments and installation of new instruments including HPLC.• Planned and coordinated for Stability study initiation for some new products and coordinated for further analysis. Quality Assurance:• Worked and trained 40 CQA Core QA SOP for establishing the quality systems in Siflon Group. • Structured the QA operations in systematic way with job allotment wide Job descriptions.• Coordinated for Change control and deviation writing practices.• Managing the quality team for their works assigned (7 members) Renovation Project management:• Layout planning, identification of water and compressed air points further vendor scrutiny • Coordination for renovation works with Civil, AHU, GMP drains, electrical vendor, QC tables, Painting and Laphum works. Innovative Improvements made for better functioning of firm:• Designed faster track Raw Material Procurement estimation excel sheet for timely, procurement and analysis of raw materials and cost reduction.• Innovative initiative for better Production batch planning based on previous sales data for better timely stocking and timely analysis and release.

Project lead for CTD preparation projects for submission of PSFs to WHO, EDMFs, CTA, NDA to DCGI and International expansions for Combination vaccines, rDNA vaccines and Monovalent vaccines.Regulatory strategy development for submission and changes made in Facility, Manufacturing, Testing.Variation submissions and responding to queriesRevision of variation guidelines

Hyderabad Area, India

• Project lead for CTD preparation projects for submission of PSFs to WHO, EDMFs, CTA, NDA to DCGI and International expansions for Combination vaccines, rDNA vaccines and Monovalent vaccines which involves below key activities:o Development of Submission Strategy for the project taken up.o Guiding the project RA team in Sections framing from available data.• Summarising the Highlights of New / revised Regulatory guidelines for quick reference of RA team and Functional teams.• Worked for revision of Post Approval Change guideline of CDSCO for Biological products• Worked for revision of Drugs and Cosmetic Act rules with related to Biological products• Slides preparation for development and licensed vaccines for SEC and WHO meetings

Hyderabad, India

Project lead for CTD preparation projects for submission of PSFs to WHO, EDMFs, CTA, NDA to DCGI and International expansions for Combination vaccines, rDNA vaccines and Monovalent vaccines which involves below key activities:o Development of Submission Strategy for the project taken up.o Guiding the project RA team in Sections framing from available data.o Gap Assessment of the available data and communicating the gaps identified to functional teams for filling them for fruitful submission.o Preparation of DP sections and review of DS sections for accomplishment of Submission as per the timeline.o Identification of issues and risks underlying the project and strategy development with different options for resolving them, by bringing the functional teams in to agreement with the feasible option.o Responding the Queries raised by Indian NRA, WHO and International regulatory authorities and fulfillment of commitments for achieving the targeted approvals and further license maintenance

Hyderabad Area, India

• Preparation and Submission of CTDs and Technical dossiers for Viral vaccines, rDNA vaccines and combination vaccines.• Preparation and Submission of responses to regulatory Authorities.

Masters In Pharmacy, Pharmacy, Distinction (82%)

Activities and Societies: Secured 12th rank out of 400 attendees in JNTU Entrance examination for M.Pharmacy seat allotment. Phytochemical.

Masters In Pharmacy

Secured 12th rank out of 400 attendees in JNTU Entrance examination for M.Pharmacy seat allotment.