23 Cdsco Jobs

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.

Head of Quality Assurance & Regulatory Affairs (QA/RA) Job Description As the In-charge of Quality Assurance and Regulatory Affairs (QA/RA), you will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems. This role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality products enter emerging, regulated, and clinical global markets. You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company. Continuous improvement and ad-hoc issue resolution to drive improvement of quality operations, at the lowest costs and in full compliance of all relevant regulations and standards. Duties/Responsibilities Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets. Ensure that regulated processes and systems are always inspection ready. Oversee the performance of internal and external audits. Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs. Serve as person responsible for regulatory compliance (PRRC). Other duties as assigned. - To lead in new products registration and license renewal compliance to local regulations, as well as GMP, GDP and ISO requirement. - Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements. - Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements - Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. Responsible to improve and implement the QMS for ISO 9001:2008 and ISO 13485:2003, European Medical Device Directive MDD 93/42/EEC Follow-up the Indian GMP regulation and ensure compliance of the technical file according to Indian regulation. Responsible for monitoring of critical processes for site in compliance of operations, Quality Management and regulatory affairs. Point of contact between the responsible countries, HQ and Asia regional office in ensuring processes and local activities meet the respective country's regulatory and legal requirements. Management Representative for the company. To be involved in Management review committee and an Executive Board member. - Drives resolution of issues. Communicates issues, impact and outcomes to the management team. - Responsible for ensuring compliance to the submission standards, procedures and policies in India. Author and refine technical documentation necessary to maintain our current CE Markings and to complete a design dossier suitable for submission for new products. Maintain and monitor our quality system within the company: changes, CAPA, Non-conformities, Complaints, PMS, continuous improvement, trend analysis, etc. Train all employees to the QMS, and assess skills, knowledge and QMS application. Perform internal audits to assess the company compliance with our QMS. Contribute to maintaining quality system related documentation including supplier records, audits, purchase and manufacturing batch information. Work with our Notified Body to maintain current certifications Qualifications 10 years of QMS experience and demonstrated leadership experience. 10+ years of experience in regulatory affairs and quality assurance in the healthcare industry Extensive experience hosting regulatory inspections and interacting with regulators Strong understanding of global registration requirements and demonstrated track record of successful market access. General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices Proven ability to create culture of accountability and ownership Proven track record with establishing and maintaining strong internal and external partnerships. Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners. Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations. Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects. Highly independent and self-motivated and integrates well within a team. Ability to prioritise and make decisions. Good problem-solving abilities able to identify salient issues, consider alternative solutions and evaluate the most appropriate course of action. Strong organisational and team-working skills including commitment and flexibility. Sound work ethics. Looks beyond boundaries of own job to support others. Education Bachelors degree required in a science, engineering field or related discipline. Masters/MBA is a plus

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quality Audit and maintain the company anytime audit ready. Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs. To monitor & handle market complaints. Conduct Management review at site. Conduct Calibration of instrument & Maintain Calibration Matrix . Ensure that a respective Change Control procedure is in place and adhered to . Process validation protocol preparation & implementation. Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance. Must be capable to handle all types of Audit. To Lead and face the regulatory audits and close all queries and NC in stipulated time. To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File. Preferred candidate profile: Graduate in Science or Engineering . Post Graduation preferred. Thorough Experience in quality and regulatory areas. Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001. Regulatory functions throughout the organization including monitoring , improvement , audits, and team building. Thoroughly conversant with technical documentation requirement and preparation. Excellent MS office skills. Should have faced multiple audits from multiple agencies Should have thorough knowledge of the applicable standards Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.

Responsibilities: * Prepare documentation according to ISO 13485 standards. * Ensure compliance with EU MDR, US FDA & CDSCO guidelines. * Maintain regulatory documentation * Internal Audits

Key responsibilities Prepare and submit applications via the SUGAM portal (Form 41 & 46) to relevant authorities (DCGI, IVRI, Krishibhavan, and DAHD) for veterinary products. Compile, review, and prepare CTD/eCTD dossiers for veterinary vaccines and APIs in compliance with CDSCO and international guidelines. Handle end-to-end veterinary product registration, including new applications, renewals, updates, and query responses. Track application status, follow up with authorities, and ensure timely responses to regulatory queries and deficiencies. Support audits by CDSCO and other bodies; maintain organized, inspection-ready documentation and records. Review and approve product Labelling and packaging to ensure regulatory compliance Review change control, assess PAC applicability, and prepare related submissions. Collaborate with R&D, QA, QC, Manufacturing, and Marketing to gather technical documents and provide regulatory inputs. Review technical documents and guide internal teams on regulatory standards, including new drug applications. Stay updated on evolving veterinary regulations and support the HOD in regulatory planning and decision-making. Skill Requirement Strong understanding of Indian regulatory frameworks including CDSCO. Must have experience with the SUGAM portal and CDSCO online submission process. In-depth knowledge of Form 41 and Form 46 requirements. Dossier preparation expertise for veterinary vaccines. Ability to interpret and apply regulatory guidelines accurately. Excellent communication, coordination, and project management skills. Job Location: Kadi,Gujarat (Bus transport facility available from Ahmedabad,Kalol & Kadi) Note: Immediate Joiner will be preferred first

Roles & Responsibilities Will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders. will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department. will be responsible for regulatory submission process, including CT-NOC, marketing authorization applications, NOC & test license. will follow up with regulatory agencies to obtain the approvals to support the regulatory timelines will identify and assess regulatory risks associated with product filing. will provide regulatory guidance to company personnel throughout the research and development process. Competencies: Understanding of various regulatory requirements for new drug development Presentation & Communication Skills Interpersonal Skills Proficiency in Kannada Desired Profile : M. Pharm/M.Sc. with 2+ yrs of experience in submission of dossiers to Indian Regulatory agencies Working experience of IND and NDA filing of NCE and NBE products

To oversee and manage all aspects of the QMS to ensure compliance with global regulatory standards, including the CDSCO requirements. Job Location : Chamarajpet, Bengaluru.

Role & responsibilities QA Documents Preparation, review, & revision (such as Work Instructions, Flowcharts, SOPs, Inward Quality Plan, Technical Data Sheet, Formats, etc.) Document Control (Soft copy & Hard copy) Coordinate with QC, Production, Design team & management. Maintain master copy & distribute control copy of documents to respective departments. Gain knowledge regarding medical device applications. Developing and implementing quality systems: Including policies, procedures, and guidelines, to ensure that products or services meet the required quality standards. Conducting audits and monitoring processes to ensure that they comply with quality systems and standards. Handling Customer Complaints Handling Corrective Action & Preventive Action (CAPA). Suggest & implement new document/ process/ system. Preferred candidate profile Should be a Graduate of Biological Science. (Bsc & Btech Biotechnology) Minimum 1 to 2 years of relevant experience required Certified internal auditor for ISO 13485;2016. Experience working with 3D printers in the healthcare segment. Strong organisational skills that reflect the ability to perform and prioritise multiple tasks seamlessly with excellent attention to detail.

Job Title: Senior Manager- Logistics Department: Logistics / Supply Chain Management Location: Vashi / Head Office Reports To: Logistics Head Job Description: We are seeking a highly experienced and motivated Senior Manager Logistics to oversee end-to-end international trade operations, including import/export logistics , regulatory compliance , and banking documentation . The ideal candidate will bring a deep understanding of DGFT, CDSCO, Customs, and global trade regulations. Key Responsibilities: Manage import/export logistics for raw materials, capital goods, and high-seas trade. Handle customs clearance , DGFT documentation , MEIS/RODTEP claims, and AD Code registrations. Coordinate with CHA agents , ports (JNPT, Sahar), and international banks. Ensure timely and accurate filing with regulatory authorities (CDSCO, FDA, PHARMEXCIL, IMC). Liaise with DGFT, CDSCO, GST, MPCB, RBI, FEMA and other regulatory bodies . Attend hearings and manage legal responses (customs, GST, ED disputes). Work with banks for LCs , bill discounting, foreign payments, and remittance documentation. Collaborate with internal teams (Finance, Purchase, Admin, QA/RA) for smooth logistics operations. Ensure accuracy and timeliness in quarterly filings, license renewals, and logistics reporting. Candidate Profile Experience: 5-10 years in international logistics, import/export operations, and regulatory compliance. Knowledge of: DGFT, CDSCO, Customs, RBI/FEMA, GST, MEIS/RODTEP schemes. Tools: ERP systems, MS Office, ICEGATE, DGFT & CDSCO portals. Skills: Leadership, Coordination, Documentation, Negotiation, Communication. Why Join Us? Be part of a leading chemical & pharmaceutical organization . Engage in challenging, cross-functional international operations . Work in a compliance-driven and growth-oriented environment . Apply Now If you're passionate about managing logistics operations and working in a high-impact role apply on Naukri or send your resume to hrd@calyxindia.com and become a part of the Calyx growth journey!

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (both Open and Closed Parts) for submission to national and international regulatory authorities. Ensure data integrity and compliance with ICH and other global regulatory guidelines . Regulatory Documentation & Submissions: Prepare, review, and submit CDSCO-specific checklists for New Drug Applications (ND) and SND (Subsequent New Drug) filings for APIs. Regulatory Compliance: Stay current with evolving regulations and guidelines issued by CDSCO, ICH, USFDA, EMA , and other global regulatory bodies. Assist in audits and regulatory inspections by preparing and presenting required documentation. Liaison with Regulatory Authorities: Coordinate with Local FDA & CDSCO Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication. If interested please share updated resume on corporate.hr@exemedpharma.com

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name

#Hiring Regulatory Affairs Manager for one of the reputed MNC into Healthcare industry. Position Title: Regulatory Affairs Manager Location: Gurugram About Role:- The Regulatory Affairs Manager will be responsible for managing the regulatory strategy and ensuring the compliance of medical devices/IVD with applicable regulations. The candidate should have relevant years of experience in Regulatory Affairs. Preferably, complete knowledge of Indian Regulatory Requirements with in-depth understanding of D&C Act, MDR 2017& BIS. This role involves working closely with cross functional team. The manager will monitor regulatory changes, support product submissions, and ensure timely approvals to maintain product marketability in India. Key Accountabilities:- Provide Regulatory Support for timely new product launches. Well versed with filing application of Import Registration/Import license/Test License on SUGAM portal and NSWS & BIS Regulations & Certification. Stay abreast of regulatory procedures and changes in regulatory climate. Responsible for managing BIS application and submission procedures To review Medical Device dossier and technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents and take appropriate actions to obtain regulatory approvals as planned. Address queries from CDSCO/NSWS on submitted applications, provide regulatory support and assist in preparing a response to regulatory authoritys questions within assigned timelines. Responsible for managing modifications to a device after it has received regulatory approval. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. Timely tracking and reconciliation of routine submissions/activities/Query response Post-Market Surveillance: Manage post-market surveillance activities, including adverse event reporting, field safety corrective actions, and vigilance reporting. Minimum Knowledge & Experience required for the position: Bachelor's/ Masters degree in a relevant field, such as life sciences, or regulatory affairs. Around 5+ years of relevant experience in Healthcare Industry (Medical Devices/IVDs) in Regulatory Affairs (MNCs) is desirable. Skills & Capabilities: Hands-on experience with the NSWS/ SUGAM portal and CDSCO online submission process. Strong understanding of Indian regulatory frameworks including CDSCO & BIS. Attention to detail and critical thinking skills Ability to work collaboratively with cross-functional teams. Note:- Looking Male candidate with decent exposure into RA role with reputed MNC's. If above role matches with your experience & aspirations than share CV to: recruit.corp12@apexservices.in

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

The ideal candidate will have experience in graphic design with a focus on regulated environments and a strong understanding of pharma-specific packaging components such as labels, cartons, leaflets, and blister packs.

About Janitri Janitri is a Med-tech company that develops IoT-based smart pregnancy and newborn monitoring devices. Apart from a recent feature in Shark Tank, Janitri has won numerous awards and accolades for its life-saving innovations. About the position: We are seeking a highly motivated and experienced Senior Regulatory and Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the product lifecycle of Class II medical devices. This role requires a deep understanding of regulatory affairs, quality management systems, and strong attention to detail. Roles and Responsibilities: Regulatory Compliance: Lead regulatory submissions (510(k), Technical Files, Design Dossiers) for Class II medical devices to regulatory authorities (FDA, Notified Bodies, etc.). Interpret and apply regulations (FDA QSR, ISO 13485, MDR, etc.) to ensure compliance of products and processes. Monitor changes in regulations and communicate potential impacts to relevant stakeholders. Quality Management Systems: Develop, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards. Conduct internal audits and oversee external audits to assess QMS effectiveness and identify areas for improvement. Manage corrective and preventive action (CAPA) processes to address quality issues and prevent recurrence. Product Lifecycle Management: Provide regulatory guidance and support to cross-functional teams throughout the product life cycle, from product development to post-market surveillance. Review and approve design control documentation, including design inputs, verification/validation plans, and risk management activities. Support regulatory assessments of product changes and design modifications. Compliance Documentation: Prepare and maintain regulatory documentation, including regulatory submissions, technical documentation, and quality records. Ensure documentation is accurate, complete, and in compliance with applicable regulations and standards. Required Skills: Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred. Minimum of 10+ years of experience in regulatory affairs and quality assurance within the medical device industry, with specific experience in Class II devices. In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards. Experience with regulatory submissions, including 510(k) applications and Technical Files. Strong analytical skills and attention to detail. Excellent written and verbal communication skills. Ability to work effectively in a cross-functional team environment.

Responsibilities: 1.Document Preparation: a) Assist in preparing and reviewing regulatory submission documents (e.g., CDSCO). b) Ensure accuracy and compliance with regulatory guidelines. 2.Filing and Submissions: a) Help coordinate and submit documents to regulatory bodies. b) Maintain detailed records of all regulatory submissions and approvals. 3.Compliance Support: a) Monitor product compliance with current regulations and standards. b) Help ensure documentation aligns with regulatory changes and updates. Comprehensive understanding of products and technologies Review the unique products and search the regulatory data of particular product. Develop and write clear arguments and explanations for new product licenses and license renewals Provide the strategic advice to senior management throughout the development of new product Take part in the development of marketing concepts and approve packaging and advertising before a products release Monitor and set timelines for licence variations and renewal approvals. Update/Report the everyday work to the Reporting Manager. Skills: Legal Knowledge Strong Writing and Documentation Decision-making Time Management Situational Analysis Preferred qualification: Bachelors degree (or equivalent) in a relevant discipline 2-3 year of experience

Job description Coordination, implementation, maintenance of QMS as per ISO13485 Prepare and Control of QMS Documentation and liaise with external parties on matters relating to Quality Systems. Review Post Market Surveillance records & reporting Required Candidate profile Candidate must have worked on regulatory part of diagnostics or IVD Must have experience is CDSCO Should be from lifesciences background CAPA, OOS knowledge is must

Role & responsibilities: Prepare and manage regulatory submissions (e.g., Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), marketing authorization submissions). Ensure clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP), ICH guidelines, and local regulations. Track regulatory timelines and manage submission deadlines for new drug applications, clinical trials, and so on. Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data. Adhering to GCP to meet regulatory requirements, Verification of deviations from the Protocol, SOPs, GCP and other applicable requirements and taking preventive action and corrective action to prevent recurrence. Preparation of audit reports and suitable corrective and preventive action plans. To have experience in the Ethics Committee related activities. To liaison with Local Drug Authorities (DCGI/CDSCO) for regulatory approvals of Test Licenses, Amendments, for conducting BA/BE clinical studies in India. Timely notification to DCGI/CDSCO for study related updates Communicate with regulatory agencies to clarify requirements and resolve issues related to clinical trial approvals and submissions. Manage responses to regulatory queries and facilitate interactions between the client and regulatory bodies. To search literature on healthy population to support BA/BE NOC application To liaise CBN for regulatory approvals for conducting clinical studies in India. To coordinate with global regulatory authorities for regulatory strategic for various products and services Proactive co-ordination of all the necessary activities required regulatory submission. Preferred candidate profile: Education : Bachelor's degree in life sciences, pharmacy, or related field (Masters or advanced degree preferred). Experience : 5+ years of experience in regulatory affairs within a CRO or pharmaceutical/biotech industry, with at least 2 years in a managerial role. Knowledge : In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH), clinical trial regulations, and submission processes. Interested applicants can apply with their updated profile or Can send to email to hr@qpsbioserve.com

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name

Key Responsibilities: Regulatory Strategy Development: Collaborate with cross-functional teams to develop and execute regulatory strategies for biological products, ensuring alignment with corporate objectives and regulatory guidelines. Regulatory Submissions: Prepare and submit regulatory documents, including CDSCO dossiers/queries, variations including scale-up changes, and annual reports, while ensuring accuracy, completeness, and timeliness. Regulatory Intelligence: Monitor and interpret regulatory requirements, guidelines, and trends related to biological products to inform decision-making and maintain compliance. Cross-functional Collaboration: Work closely with R&D, Clinical Development, Quality Assurance, and Manufacturing teams to support regulatory activities, resolve regulatory issues, and facilitate product development and registration. Regulatory Compliance: Ensure compliance with applicable regulations and guidelines, including those set forth by regulatory authorities such as the CDSCO, FDA, EMA, and other global agencies, throughout the product lifecycle. Regulatory Agency Interactions: Serve as a primary point of contact for regulatory agencies, participating in meetings, teleconferences, and regulatory inspections as needed to address inquiries and facilitate approvals. Product Labelling and Promotional Material Review: Review and approve product labelling, promotional materials, and advertising to ensure compliance with regulatory requirements and company policies. Regulatory Document Management: Maintain regulatory files and documentation in accordance with company procedures and regulatory standards, ensuring accessibility and traceability. Interested candidates can share CVS at sheetal.c@cielhr.com