2122 Regulatory Affairs Jobs - Page 43

Following up on new business opportunities and setting up meetings. Calling prospects/Clients daily and following up about the open requirements. Ability to work on given targets and achieve the same. Requirements Any Bachelor Degree Very Good English Communication Skills Ready to work in Shifts (10AM to 7PM or 2PM to 11 PM) Ready to make calls in US, UK and Europe as per their timezone About Company / Benefits 5 days a week work culture Performance awards and rewards Flexible work timings Performance based Incentives

Manager - DSRM (Aggregate and SDEA) 1. Managing the Safety Data Exchange Agreement mailbox, to track the emails received and ensure appropriate action is taken. 2. To ensure appropriate agreements are in place with prospective and existing business partners and ensure timely execution and renewal of agreements 3. To liaise with cross functional teams to seek additional information 4. To ensure compliance to the agreements and be audit / inspection ready. 5.Preparing and maintaining the aggregate report writing plan to plan and keep a track of the global aggregate report submissions 6. Preparing and maintaining the aggregate report compliance tracker and ensuring compliance and appropriate co...

Quality Assurance: Develop and implement quality assurance policies and procedures for the manufacturing plant. Monitor and inspect raw materials, in-process production, and finished goods to ensure compliance with company quality standards. Conduct regular audits and inspections to identify potential issues and ensure adherence to quality control protocols. Process Improvement: Collaborate with cross-functional teams to identify areas of improvement in the manufacturing process. Analyze production data, identify trends, and recommend corrective actions to enhance product quality and process efficiency. Implement continuous improvement initiatives to reduce defects, waste, and production dow...

Job Description Overall Single Point of Contact for Quality IT Projects (such as LIMS, Chromatography, QAMS, EDMS, LMS etc.) Finalization of URS in alignment with sites (India + Global). Harmonization of system and processes in line with regulatory requirements and compliances. Testing and Validation of IT applications in line with URS for QA/ QC/ Common applications. Keeping organization up to date on the requirement for smart QA/ QC. Defining SOP and training of personnel. Supporting operational team. Keeping senior management updated on the organization status. Keeping senior management updated on the organization status. Facing Regulatory Audits at site as and when required. Keeping site...

Responsibilities: Ensure compliance with regulatory requirements at SEZs & customs clearance. Manage MOOWR, ICD, DGFT licenses & renewals. Collaborate with R&D on product registrations & variations.

Assist in preparing and submitting regulatory documentation for sterile products (e.g., FDA 510(k), CE Technical Files, DMFs). Support regulatory strategy development and maintain knowledge of global sterile product regulations. Help manage product registrations, licenses, and renewals in various markets. Collaborate with R&D, Quality, and Manufacturing teams to ensure regulatory compliance during product development and changes. Track regulatory requirements, guidance updates, and assist in audit preparations. Maintain organized regulatory files and documentation.

Role & responsibilities Build, strengthen, and maintain strategic relationships with politicians, bureaucrats, government departments, and other key influencers . Drive all government and administrative liaisons related to land, licenses, factory approvals, environmental clearances, labor laws, etc. Act as the companys representative in front of government authorities, regulatory bodies, and political leaders . Proactively anticipate and mitigate regulatory risks impacting the business. Facilitate resolution of legal or operational roadblocks through government or administrative channels. Act as a key advisor to management on policy matters, government reforms , and political climate relevan...

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

Accountable to the GRL and Global Regulatory for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices May be responsible for relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations / renewals / variations , label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc) May be required to perform scenario planning when multiple regulatory strategies are being ...

Assistant Officer - Nutrition Science and Analytical Services Job Details | Tata Consumer Products Limited Search by Keyword Search by Location Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Assistant Officer - Nutrition Science and Analytical Services Tata Consumer Products Limited Assistant Officer - Nutrition Science and Analytical Services What are the Key Deliverables in this role? Financial Outcomes Provide timely analytical support to the Regulatory Affairs function to ensure regulatory compliance. Deliver prompt support to the Quality Assurance team to enable informed quality and business decisions based on analytical data. Continuousl...

Transport is at the core of modern society. Imagine using your expertise to shape sustainable transport and infrastructure solutions for the future? If you seek to make a difference on a global scale, working with next-gen technologies and the sharpest collaborative teams, then we could be a perfect match. Responsibilities: - Certification Management New emission certification Modification certification (Emission Related Components change) Modification report (OEM, Importer, Machine change) Monthly report of Sales volume Report of parts defect related to failure parts (quarterly and annually) COP management, execution and reporting In-service monitoring management and report PEMS testing, in...

Regulatory Expert: Manage pharma formulations’ compliance in CIS, LATAM, Africa. Compile/review ACTD/CTD dossiers. Address MOH queries. Ensure artwork/sample compliance. Coordinate global submissions. Maintain records. Lead regulatory team. Required Candidate profile Regulatory Affairs:5 yrs in pharma formulations CIS/LATAM/Africa. Skilled in ACTD/CTD dossiers, MOH queries. Strong coordination, documentation & team leadership. Pharmacy/Regulatory degree preferred. Perks and benefits 2 & 3rd Sat off Paid leave – 21 Public Holiday- 12

Managing PAN India Litigation, Legal documentation related to court matters, Initial Case Investigation and Assessment. Legal research, drafting legal documents. attending to legal and regulatory issues and managing legal compliances of the org

1. Regulatory Submissions: Preparation and compilation of dossiers in CTD/eCTD formats for domestic and international markets (ROW countries). Submission of registration applications for new products and variations (post-approval changes). 2. Documentation: Review and verification of technical documents such as Product Information Leaflets, Labels, SPC, COAs, Stability Data, Product Development Reports, etc. Coordination with R&D, QA, QC, and production teams for required documents and data. 3. Regulatory Compliance: Ensure products and documentation comply with applicable regulations and guidelines (ICH, WHO, FDA, EMA, CDSCO, etc.). Monitor regulatory changes and ensure timely updates to in...

Regulatory compliance, dossier preparation, CER, risk management (ISO 14971), audit support, CDSCO/FDA licensing, SOP drafting, validation reports, NPD change control, ,ensuring product certification in domestic ,international medical device markets Required Candidate profile B.Pharm, M.Pharm, Biomedical Engineering, Life Sciences, Regulatory Affairs Certification. Perks and benefits Food, PF, Medical Insurance

Title: Senior Regulatory Associate Date: 2 Jul 2025 Location: Bangalore, KA, IN Job Description We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.comLooking to jump-start your careerWe understand how important the first few years of your career are...

SANOFI HEALTHCARE INDIA PRIVATE LIMITED is looking for Associate Scientific Writer to join our dynamic team and embark on a rewarding career journey Develop and write scientific manuscripts, reports, and presentations for various audiences. Conduct literature reviews and synthesize research findings to support scientific writing. Collaborate with researchers, clinicians, and other stakeholders to gather and verify information. Ensure the accuracy, clarity, and compliance of scientific content with industry standards and regulations. Manage multiple writing projects simultaneously, ensuring timely delivery. Stay updated with the latest advancements in scientific writing and research methodolo...

Position: Regulatory Affairs Executive Location: Andheri (E) Role & responsibilities Ensure that the company's products comply with the regulations of the regions where they are distributed. Keep up to date with national and international legislation, guidelines and customer practices. Prepare dossiers, documents and samples as per requirement of markets for participation in tenders. Collect, collate and evaluate scientific data from a range of sources and prepare dossiers as per the market demand in CTD /ACTD formats. Monitor and set timelines for registrations variations and renewal approvals and submissions. Write clear, accessible product labels and patient information leaflets. Advise c...

Designation: Assistant Manager - Canada Market Experience: 7-11 Years Reporting: Head RA Qualification: B.Pharm/M.Pharm Job Location: Pune Dosage form: All types 1. Strong experience in Regulatory Affairs for Canada or Europe market. 2. To build regulatory strategy for submission,evaluation of changes and maintenance of product life-cycle for different dosage forms. 3. Compilation of dossiers in CTD, eCTD. 4. Compilation and submission of queries and variations. 5. Regulatory compliance with Front offices and with Plant. 6. Review of documents, artworks 7. Review of change controls 8. Gap analysis for new product filing 9. Maintaining product Life cycle 10. Liaise with all cross functional d...

To prepare the Registration and Renewal dossiers in CTD, ACTD & Country Specific format To prepare the dossiers for allotted countries Timely answering the queries EXP in ROW market B. Pharm, M.Pharm,Science graduate/PG Required Candidate profile Exp as Head of department for ROW-Regulatory affairs Exp in Team handling kindly send resume to hr1@flamingopharma.com,sunil@flamingopharmacom

Prepare, review, file, and support premarket documents for global registrations for assigned projects. .Review pre-clinical, and clinical protocols and associated reports to be used. Collaborate with business unit and international regulatory affairs

Job Description: Regulatory Affairs Assistant Manager / Manager Injectable & OSD Facility Department: Regulatory Affairs Location: GIDC Ankleshwar Key Responsibilities: Prepare and submit dossiers (CTD/ACTD) for ROW & US markets. Ensure compliance with local regulatory guidelines and GMP standards. Liaise with regulatory agencies and respond to queries promptly. Manage product registrations, renewals, and variations. Monitor regulatory updates and ensure adherence to changes. Support quality audits and review labeling/artwork for compliance .

Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quali...

Role includes handling government approvals, compliance, and regulatory coordination. Strong liaison skills and relevant qualifications required. Provide guidance on regulatory matters to the management team. Required Candidate profile Strong knowledge of real estate regulations and processes.Skilled in handling approvals and navigating complex regulatory environments.Holds a degree in Law, Business Administration, or related field.

Preparation of CTD(Common Technical Documents) and ACTD(Asian Common Technical Documents) Dossiers for CIS (Commonwealth Independent States) and ROW (Rest Of World) Reviewing factory documents like Specifications, MOA (Mode Of Action), COA (Certificate Of Analysis), BMR (Batch Manufacturing Records), PVP (Polyvinylpyrrolidone), PVR (Pharmaco Vigilance Regulation), MFR (Master Formula Records), Stability Data etc.Reviewing DMF (Drug Master File) Reviewing Artworks and Labels. Co-ordinating with Factory for Documents. Preparation of Normative Document of Registered productsin CIS markets.Preparation of Excel sheet of Regulatory status. Response to Queries. Filing of Documents / Dossier. Prepar...