15 Dcgi Jobs

Job Title: Study Start-up and Regulatory Submission Manager Location: Navi Mumbai, India Experience Required: 5 10 years Employment Type: Full-Time Working Days: 2nd & 4th Saturdays; All Sundays Off Job Description We are seeking an experienced Study Start-up and Regulatory Submission Manager to join our clinical operations team in Navi Mumbai. The ideal candidate should have strong expertise in India-specific clinical trial operations , with proven experience managing regulatory submissions and study start-up activities . Key Responsibilities: Lead and manage Clinical Trial Applications (CTA) and regulatory submissions in compliance with Indian regulatory requirements. Drive clinical study start-up activities , including site identification, feasibility, and activation. Coordinate with ethics committees and clinical trial sites to ensure smooth and timely approvals. Prepare, review, and submit study-related documents to DCGI (Drug Controller General of India) and other relevant authorities. Ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs throughout the process. Collaborate with cross-functional teams to ensure on-time study initiation. If you or someone you know fits this role, apply directly through the job post or share your resume at navya_b@trigent.com

Additional features :- Fully accustomed to Customs, DCGI, FSSAI, DGFT, RBI, Bank procedures related to Imports. Domestic sourcing also will also be one aspect of the overall profile. Pharma/Chemicals INDUSTRY experience preferred.

Role & responsibilities Liaison with Food & Drugs Control Administration, Gandhinagar/circle offices/CDSCO for various applications including but not limited to Product Permissions for manufacturing COPPs Various certificates for tender (FSC, Performance certificate, Non-conviction certificate) Inspections for WHO GMP/Schedule M GMP certification Technical persons approval Technical person application verification. Liaison with CDSCO, West Zone, Form 29 Export licenses Loan license Manufacturing licence renewal for all plants Wholesale licences Submission of commercial batches to CDL Kasauli for testing Submission of quarterly returns to NCB/CBN Handling NSQs Experience in submissions through Sugam, NSWS and ONDLS portals Preferred candidate profile Must have experience in the pharmaceutical industry

Conduct research and development in pharmaceutical analytics. Develop and implement R&D strategies and plans. Monitor and analyze R&D performance and trends. Prepare R&D reports and presentations. Collaborate with other teams to achieve R&D objectives. Provide training and support to junior R&D scientists. Stay updated with the latest R&D trends and best practices.

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Roles and Responsibilities Develop new products by leading cross-functional teams through formulation development, process development, and scale-up. Collaborate with external partners (CROs) on OSD product development and registration dossiers preparation. Ensure compliance with regulatory requirements for solid oral products at CDSCO and DCGI. Manage budgets, resources, and timelines for R&D projects to achieve business objectives. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry with expertise in AR&D. Bachelor's degree in Pharmacy (B.Pharma) followed by Master's degree (M.Pharma). Strong understanding of formulation development, formulation research, Nutraceuticals, OSDs. Proven track record of successfully leading complex projects from ideation to launch.

Roles and Responsibilities Develop and implement new product ideas through CDSCO process. Oversee research and development projects from concept to commercialization. Collaborate with cross-functional teams to ensure successful project delivery. Ensure compliance with regulatory requirements (DCgi) and maintain high standards of quality control. Desired Candidate Profile 15-18 years of experience in pharmaceutical industry, preferably in FR&D or similar role. B.Pharma degree in Any Specialization; M.Pharma preferred but not mandatory. Strong understanding of formulation development, formulations, nutraceuticals, OSDs, and solid orals.

Job Profile for Regulatory Affairs : Participate and coordinate with various cross-functional teams by working closely with Quality assurance, Quality control for documents collections in dossier preparation. Dossier review and collection of required Pharmacology/Toxicology/Clinical data through literature&internetforpreparationofSummaryofProductCharacteristic and Patient Information Leaf lets (PIL). DMF Review Preparation and Management for submission of dossier in CTD, ACTD and Country specific format. Review of Analytical method validation verification Reports required for drug product development and submission in regulatory application. Review of stability data incompliance with specification. Review of additional stability studies protocols. Responsible for quality review of all documents related to submission. Preparation and Review of Process Validation Protocols and Reports. Preparation and Review of Cleaning Validation Protocols and Reports. Review of Master Specifications, STPs and Worksheets. MSDS, BMR’S, SMPC’s and TSE & BSE certificates Preparation Quantitative and Qualitative formula preparation Certification of analysis (FP), Preparation of Cover letter, declaration forms, Review of Artwork All Technical documents review doing well as per company Requirements SOP ODLS and DCA Portal Apply (Marketing Standard Certificate Additional Products apply Good Manufacturing Practices Certificate (GMP) Good Laboratory Practices Certificate (GLP) Free Sale Certificate on etc. ODLS. Collect documents for COPP application. Making Schedule for dossiers as per requirement of buyer to submit Regulatory Authority. Responding Quires of Dossier arises by the respective authorities. CDSCO - NOC application Documents preparation & applying online.

Regulatory Affairs Manager in Clinical Research @ Vimta Labs Ltd, Hyd Experience: 8-12 years of Regulatory Affairs experience in Clinical Research Industry. CTC: Based on their current CTC. Job Description Regulatory Affairs Manager Primary Responsibilities: 1.. Manage the activities of Regulatory Affairs for clinical research and ensure the implementation of effective regulatory strategies. 2. CDSCO, CBN and NCB getting approvals as required for Vimta. 2. Provide regulatory input to strategic decision making; including prioritization, and external communications 3. Provide regulatory input to in-licensing evaluations and due diligence activities 4. Provide advice about regulations to manufacturers/scientists 5. Coordinate successful submissions and approval of all applications 6. Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil applicable regulatory and quality standards. 7. Plan, undertake and manage regulatory inspections 8. Keep up to date with national and international guidelines and customer practices 9. Develop and establish standard operating procedures that convey the best practices in the company 10. Collect, collate, and evaluate scientific data from a range of source. 11. Monitor and set timelines for licence variations and renewal approvals 12. Ensures that Good Clinical Practices (GCP) are followed. 13.Responding to any quality & regulatory issues related to clinical department and taking relevant corrective and preventive actions Secondary Responsibilities: 1. Ensure Quality Control review of protocols, ICF, CRF protocol amendments, Clinical Trial Reports, Investigator Brochures and regulatory submission documents. 2. Interpretation of data. 3. Preparation and Review of Clinical Study Report Interested candidates can share their resumes to keerthana.rojanala@vimta.com Contact: Keerthana

B.Pharm / M.Pharm with 2 to 6 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience