Deepak Kumar Email & Phone Number

Delhi, India

Delhi, India

Key Responsibilities: 1. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.2. Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. 3. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions. 4. Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.5. Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle. Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.6. Prepare estimates for conducting regulatory services as part of single or multiple service proposals.Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.7. Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.8. Prepare training materials and share best practices in the regulatory area, both internally and externally.9. Participate as regulatory support in internal or external project audits.10. Participate as regulatory support on internal cross-functional initiatives.

New Delhi, Delhi, India

Major Activities/Key Responsibilities 1. Proactively manage assigned “Premedium Pharma” portfolio to deliver CMC Submission independently on time and meeting / exceeding client quality expectations for end-to-end Regulatory support. 2. Author and Review of CMC components in Regulatory Affairs for generating submission ready Renewal dossiers for pharmaceutical products and manage all aspects for various products for EU, RoW and regulated / semi-regulated Markets in eCTD/Non-eCTD electronic submissions [NeeS]/ACTD and aassessment of regional requirements (Module 1) for various dosage forms –Solids, Liquid and Semi solid dosage forms. 3. Responsible /worked on CTD Modules [Module1, Module 2 and Module 3], Artwork Change Control Activities, biological sciences, change control, CMC Regulatory Affairs, CMC Dossier compilation, Document Publishing, Dossier Writing. 4. Product lifecycle management submissions viz. Type IA/IAin, Type IB and Type II variations) / Amendments, Renewal application Health Authority (HA). Experienced in management of new marketing authorisation applications (MA’s), submissions to comply with critical timelines and experienced in handling end to end registration procedures i.e., Decentralized Procedures (DCP) with all European Agencies and National Phases (NP). 5. Dossier gap analysis (Mod. 2.3 and Mod. 3.2.S, 3.2.P and 3.2.R) and Due-diligence of in-licensing dossiers 6. Experience in providing (SmPC, Labelling. Carton and PI) Mock up activities for assigned portfolio and / or geography as per the current Rules & regulations. 7.Regulatory strategies to submit a response to CRL (Complete Response Letter) from Health Authorities (HA) or response to HA queries.Stake holder management (External and Internal) : External: Maintain excellent relationship with the regulators both central and state FDA.Internal: Work along with the different functions of the country, regional & HQ to resolve business issues

Delhi, India

* Experienced in marketing authorization applications (MAA), Post-approval regulatory Variations (CP Procedure), Package Information Leaflet (PIL), Summary of Product Characteristics (SmPC) Renewals, Labelling, Safety Variations & Control documents for post-approval regulatory submissions, Change Control Proposal Assessments.* Responsible for managing the products life cycle management ( timely submission of the application to the Health Authorities ) , RIMS (Regulatory Information Management System ) , update , PMI submission and proofreading . * Reviewing and approving the promotional material and re-packing specimens . * Health Authority Interactions: Act as the primary interface between the company and local regulatory authorities for regulatory / submission products portfolio.* Regulatory Compliance: Review and approve promotional and non-promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Coordinate review with the responsible functions in the product profile compliance .

Noida Area, India

Major Activities/Key Responsibilities1. Assists in product registrations by preparing/ requesting documentation needed for filings -Prepares registration packages for routine filings -Identifies and collects data needed -Prepares responses to deficiency letters.2. Support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. 3. Develop / maintain excellent relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies.4. Experienced in marketing authorisation applications (MAA), Lifecycle maintenance: variations, CPP, Package Information Leaflet (PIL), Summary of Product Characteristics (SmPC), Renewals, Labelling, Safety Variations & Control documents for post-approval regulatory submissions, Change Control Proposal Assessments.5. Develop product labelling, for new product and responsible for regulatory compliance to all applicable regulations for healthcare professionals and patients (SmPC, PIL, Labelling). 6. Identification of risks to project delivery and appropriate escalation with associated resolution actions. Identify moderate complex issues and present solutions to project related problems escalated by Associates / senior Associates. 7. Provide support in oversight to team members in the execution of their project responsibilities and capable of identifying when to ensure line support required to provide additional guidance and direction. 8. Regulatory strategies to submit a response to CRL (Complete Response Letter) from Health Authorities (HA) or response to HA 9. Gathered, coordinated and submitted to the FDA all maintenance documents to the heath authority and post marketing annual reports.

New Delhi Area, India

Key Responsibilities:1. Write, review and approve GMP-relevant results and or/ related tools as per area of responsibility in order to ensure compliance with cGMP and project quality results.2. Review of the various quality documents like change controls, incidents, and deviations, initiated at the manufacturing location critically, evaluate those with respect to the reporting category for different agencies and gives a recommendation for the required data generation in consultation with the corporate regulatory wherever applicable. 3. Act as liaison between corporate regulatory and manufacturing location to ensure that the manufacturing site is updated with the requirement of the agencies from time to time. 4. Review of the various quality documents like change controls, incidents, and deviations, initiated at the manufacturing location critically, evaluate those with respect to the reporting category for different agencies and gives a recommendation for the required data generation in consultation with the corporate regulatory wherever applicable. 5. Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national regulations. Ensure maintenance of regulatory databases.6. Actively follow the development and emergence of new regulatory requirements and assess their impact on the existing products and in development.7. Review and approve promotional and non-promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Coordinate review with the responsible functions in the country.

Mumbai Area, India

Key Responsibilities ▲ Review and maintain documents and record in approved doc storage system per the company policy. ▲ Monitor monthly compliance to training metrics. ▲ Support India QA Head to collecting, trending, and analyzing data for quality issues for Quality Processes.

Pg Diploma In Drug Regulatory Affairs (Dra), Pharmacy Administration And Pharmacy Policy And Regulatory Affairs, First Class

Activities and Societies: Provides tactical and strategic regulatory input and guidance on cross-functional teams. Project team.

Master Of Pharmacy (Pharmacology), Pharmacology & Toxicology, First Class

Bachelor'S Degree-Pharmaceutical Science (B.Pharmacy ), Pharmaceutical Science I Industrial & Physical Pharmacy I Cosmetic Sciences, First Class

C.B.S.E, Ist-12Th Class(Science), First Class