333 Regulatory Submissions Jobs - Page 9

Job Responsibilities Must have min 4 years of relevant experience in disclosure platform. Good experience in drafting, review and workflow in disclosure platform like disclose/PRIME etc. Hands on experience with user Acceptance testing activities. Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informe...

Job Overview Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and c...

Formulation Experience Mandatory: Well aware of EU, Australia, Ukraine & UK market requirement Dossier Preparation in ACTD & CTD Format ICH guidelines Communication skills Documents Management Stakeholder Communication

As a Biomedical Engineer, you will be responsible for designing and developing biomedical devices, equipment, software, and systems. Your role will involve evaluating the safety, efficiency, and effectiveness of medical equipment, as well as installing, calibrating, and repairing biomedical equipment as needed. Additionally, you will conduct research to enhance existing medical technologies or create new ones. Collaborating with cross-functional teams, including clinicians, you will identify user needs and product requirements. You will also be tasked with preparing technical reports, documentation, and regulatory submissions while ensuring compliance with healthcare regulations and safety s...

As Entity Controller at Tredence, you will lead accounting operations, financial reporting, audit coordination, and statutory compliance for global legal entities. Your role involves ensuring process integrity, local compliance, and timely financial close while supporting global consolidation and reporting. Ideal candidates have a strong background in accounting and audit, hands-on execution mindset, and the ability to collaborate cross-functionally in a fast-paced environment. Responsibilities include leading month-end and year-end close, GL review, journal entries, balance sheet reconciliations, and sub-ledger hygiene. You will support global consolidation, prepare statutory financial stat...

As an experienced medical writer with expertise in CTD medical writing and clinical development of medicines, your responsibilities will include the following: Writing high-quality CTD modules such as nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) to meet EU submission requirements. Addressing clinical deficiencies by providing appropriate responses. Contributing to drug development strategy. Updating documents like SmPC, Patient Information Leaflet, CCDS, Safety variations. Preparing Clinical Study Reports, Study design, and synopsis. Assisting in the formulation of clinical development strategies and reviewing study reports and published papers. Conducting liter...

The Senior Associate Regulatory Project & Resource Management plays a crucial role in supporting and streamlining regulatory projects within the organization. You will be responsible for coordinating various tasks related to regulatory submissions and compliance, ensuring that projects are completed within set timeframes while adhering to stringent industry standards and regulations. This role is perfect for individuals with exceptional attention to detail and strong project management skills. Working closely with cross-functional teams, you will allocate resources efficiently and manage communication streams to ensure precise and timely compliance with regulations. This position offers sign...

? Job Title: Vice President Indirect Taxation ???? Location: Corporate Office, Andheri, Mumbai ???? Type: Full-Time | Onsite Education : CA, CFA only ???? Preferred Background: Candidates from Big 4 firms with strong indirect tax experience ???? About the Role We are looking for a senior-level indirect tax expert to join our Finance & Accounts team. This is a strategic role focused on managing all indirect taxation matters across the organization , ensuring compliance with evolving tax laws, and providing guidance on tax-related business decisions. ???? Project Summary Youll lead the end-to-end indirect tax function including GST compliance, input tax credit, regulatory submissions, litigati...

Roles & Responsibilities: Label change updates and implementation process Logo & Package Component Labeling (PCL) changes Important Safety Information (ISI) updates Product shot index management of drug product imagery Label change content assessment binders System workflow assessments of label impacted promotional material Regulatory Information Management (RIM) archiving Preclearance & Request for Advisory Comments (RFAC) submissions Reporting/Archiving of Ad/ Promo FDA Communications (i. e. Intent to Comply, Record of Contact -ROC, Prescription Drug Marketing Act -PDMA, Dear Healthcare Provider -DHCP letters, etc. ) Veeva data entry/retrieval and collection of information Process document...

Role Overview The Sr. Associate IS Analyst DocuBridge will play a critical role in the implementation, support, and lifecycle management of structured regulatory submission solutions, primarily focused on Lorenz DocuBridge. This position requires strong technical and regulatory knowledge, project execution capabilities, and hands-on system expertise. The candidate will work closely with Regulatory Affairs, IT, Quality Assurance, and vendor partners to deliver compliant, efficient, and scalable submission systems aligned with global health authority requirements. Roles & Responsibilities Support the implementation and system management of the Lorenz DocuBridge Suite, ensuring alignment with g...

You will be responsible for driving non-clinical pharmacokinetic studies in various species for animal health products. Your role will involve planning and designing AMES, In vitro and In vivo genotoxicity studies to support impurity qualification in drug substances/products. Additionally, you will provide technical feedback for non-clinical studies, including pharmacokinetic and toxicity studies. Your duties will also include supporting study design and planning for tissue distribution studies, interpreting data, and reviewing study reports in accordance with USFDA, ICH, and OECD guidance for regulatory submissions. You will closely interface with in-house facilities and CROs to ensure the ...

Search and review scientific information / literature Drafting, submitting applications with all necessary information to RA for related Licenses required for Product Development. Identify and propose formulation strategy for product development. Read, discuss and plan Developmental activities, bring Innovation in work and adopting Digital Initiatives while doing scientific work. Visualize the developmental needs of the product. Work along with Cross functional teamtowardsto meet project milestones as per timelines. Use Scientific approach to mitigate challenges during development, scale up and Technology transfer of the product. Qualifications M.Pharm/Phd(Pharmaceutics): Experience- 2-6 yea...

Role: Senior Manager - Actuarial Job location: Lower Parel, Mumbai Role & responsibilities: 2-3 years of experience in General Insurance, not necessarily in Indian market Understands the actuarial reserving methodologies for different lines of business Ability to follow technical instructions and work independently on various processes related to reserving including data preparation and reconciliation The role will involve other analytical work like actual vs expected analysis, preparation of audit trail, helping Head of Reserving on various regulatory submissions Good understanding of data, systems Ability to work under pressure and coordinating with other business units like Claims, Financ...

You are a proactive and detail-oriented Assistant Manager in Regulatory Affairs (EU & UK) with a Masters Degree in Pharmacy (M.Pharm or equivalent) having 4 to 6 years of experience. You will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines. Your key responsibilities will include conducting comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets, performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards, developing and implementing ...

As the Assistant General Manager for Nasal Spray Formulation Development in the Research & Development department at the R&D Center in Chinchwad, Pune, you will be responsible for leading the development of innovative nasal spray formulations. Your role will involve steering projects from concept to commercial scale-up, focusing on designing, developing, and optimizing nasal spray drug products to ensure regulatory compliance and meet quality standards. You will be leading a team of formulation scientists and collaborating with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Your key responsibilities will include: - Developing and t...

You will be responsible for providing highly advanced expert support and functional and technical leadership to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. Your main tasks will include developing and applying biostatistics and programming methods to ensure valid conclusions, as well as providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. Additionally, you may also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics, and reporting of clinical trial data, you may indepen...

The role of General Manager, Veterinary Sciences at Syngene International Ltd. in Bangalore is a highly strategic position responsible for leading the BBRCs in vivo research operations. As the Head of Veterinary Sciences, you will oversee a 50,000 sq. ft. AAALAC-accredited facility supporting various therapeutic and functional areas. Reporting to BMS Veterinary Sciences leadership and the Head of Site Operations, you will play a crucial role in the BBRC Operations Leadership Team. Your main responsibilities will include ensuring high-quality support for in vivo pharmacology, DMPK, toxicology, and translational research within the Veterinary Sciences BBRC function. You will collaborate with g...

As a Manager of Biostatistics at Syneos Health, you will play a crucial role in ensuring that the Biostatistics department meets project timelines, delivers high-quality results, adheres to project requirements and SOPs, and operates within budget constraints. Your responsibilities will include participating in the development of department SOPs, overseeing staff development and training, promoting standardized processes, and facilitating succession planning. You will be responsible for setting goals for direct reports, managing their performance, identifying training needs, supporting development plans, mentoring, and coaching staff members. By actively participating in hiring, onboarding, ...

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, a...

Role & responsibilities Review of post approval changes and evaluating its impact on the products. Preparation of appropriate post approval submissions such as PAS, CBE 30 & 0, and annual reports. Management of product life cycle. Managing Team Dosage Form : Solid Oral / Nasal / Liquid/ Ophthalmics Preferred candidate profile 10+ Years of USFDA post approval submission experience USFDA Experience Exposure to ANDA /NDA post approval submissions Please share updated CV on hr19@hectorandstreak.com

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the product lifecycle through obsolescence. Your responsibilities will include assessing changes made to the device post-launch to determine the regulatory impact of these changes on current clearance. You will ensure regulatory compliance by conducting thorough assessments and submitting the necessary documentation for product clearances and approvals from regulatory bodies such as the FDA and Notified Bodies. In this role, you will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based on regulatory changes. You wil...

About Us: InSilicoMinds is a leader in the application of computational modeling and simulation (CM&S) for pharmaceutical research and development. We focus on harnessing cutting-edge in silico technologies to streamline drug design, formulation development, and regulatory submissions. Our innovative approaches help to accelerate drug discovery while optimizing formulations and ensuring high-quality manufacturing processes. Position Overview: We are looking for a highly skilled and motivated Computational Chemistry Expert with hands-on experience in retrosynthesis and reaction simulation. The ideal candidate will have deep expertise in computational chemistry tools and software, with a focus...

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.

Role & responsibilities Job Title: International Regulatory Affairs (IRA) Sr. Manager Location: Ahmedabad -HO Markets: CIS (Including EAEU), LATAM (Central and South America), Middle East, Africa, South East Asia. Key Responsibilities: 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap ...

1.To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all Latam and CIS , ROW Countries and other country as per company requirements. 2.Responsible for final review of dossier before submission. 3.To coordinate with technical team for documents required for dossier. 4.Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. 5.Reviewing artwork for products as per relevant regulatory authority requirements. 6.To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the re...