Regulatory Affairs Specialist - Pharmaceutical
Intas Pharmaceuticals Limited,
مجموع سنوات الخبرة :10 years, 4 أشهر
Handle online Portal of Central Drug standard control organization (CDSCO) office for regulatory submissions of pharma products- Submission of New Drug applications and Human Clinical trial application - Phase I, II, III, IV- BA/BE Export application and Test License application- Manufacturing / Import of New Drug for Marketing - Import & registration of finished formulation, Active Pharmaceutical Ingredients and Medical Device - Post approval changes like CMCs and pack insert updates of drug products - RCGM Submission for R&D activities and pre-clinical toxicity study of vaccines- Dual use NOC application - Import and export application of Narcotic & Psychotropic substance - Regulatory follow up with Central Drug standard control organization (CDSCO) office and submit notification - Artwork approval for new and existing products - Coordination with multiple departments of organization for smooth run of projects - Maintaining strong PRO relation at government bodies - Set timelines for project execution - Overseeing all aspects of license renewals, online portals renewals and import permission - Participate in government organized training program - Providing tactical guidance to colleagues that align with department regulations - Provide strategic and operational input to program team to achieve program objectives while ensuring compliance with applicable regulatory requirements - Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan - Serve as point of contact with regulatory authorities, leading and managing regulatory interactions, building trusted relationships with regulatory authorities - Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success - Maintain currency of regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance - Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed-
Handle online Portal of Central Drug standard control organization (CDSCO) office for regulatory submissions of pharma products- Submission of New Drug applications and Human Clinical trial application - Phase I, II, III, IV- BA/BE Export application and Test License application- Manufacturing / Import of New Drug for Marketing - Import & registration of finished formulation, Active Pharmaceutical Ingredients and Medical Device - Post approval changes like CMCs and pack insert updates of drug products - RCGM Submission for R&D activities and pre-clinical toxicity study of vaccines- Dual use NOC application - Import and export application of Narcotic & Psychotropic substance - Regulatory follow up with Central Drug standard control organization (CDSCO) office and submit notification - Artwork approval for new and existing products - Coordination with multiple departments of organization for smooth run of projects - Maintaining strong PRO relation at government bodies - Set timelines for project execution - Overseeing all aspects of license renewals, online portals renewals and import permission - Participate in government organized training program - Providing tactical guidance to colleagues that align with department regulations - Provide strategic and operational input to program team to achieve program objectives while ensuring compliance with applicable regulatory requirements - Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan - Serve as point of contact with regulatory authorities, leading and managing regulatory interactions, building trusted relationships with regulatory authorities - Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success - Maintain currency of regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance - Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed
Handle online Portal of Central Drug standard control organization (CDSCO) organization office for regulatory - submissions of pharma products - Submission of New Drug applications - Manufacturing / Import of New Drug for Marketing - Regulatory follow up with Central Drug standard control organization (CDSCO) office - Artwork approval for new and existing products - Coordination with multiple departments of organization for smooth run of projects - Maintaining strong PRO relation at government bodies -Set timelines for project execution.
Handle online Portal of Central Drug standard control organization (CDSCO) for regulatory submissions of pharma products.
Follow up with regulatory body for timely approval.
Manufacturing / Import of New Drug for Marketing.
Import & registration of finished formulation, Active Pharmaceutical Ingredients, Cosmetic Products and Medical Device.
Maintain smooth flow of organization.
Regulatory follow up with Central Drug standard control organization office.
Maintaining strong PRO relation at government bodies.
Set timelines for project execution.
Completed industrial Project on Extended release tablet of Lornoxicam.
Completed academic project on novel azetidinone derivatives.