24 Regulatory Submission Jobs

Responsible for Medical Device and Drug registration in CDSCO, State FDA office and other government office. Lead negotiations with key health authority agencies during development, registration, and product lifecycle activities to resolve regulatory issues and/or negotiate approvals; establish and maintain proactive and professional communication & relationship with agencies. Execution of Regulatory Submission plan in each of countries in hub. Representing FME India in highly visible and potentially intense forums such as FICCI/CII/APACMED for new regulations impacting the business in interactions with Government and Forum meetings. Identify key officials, develop, and execute plan to engag...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Description Senior Medical Writer (CTT & redaction) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem...

*Must have specific experience as a WHO International Nonproprietary Names (INN) Expert/Advisor and be familiar with INN guidelines, either from the WHO side or ffrom the pharmaceutical space* Brand Institute (BI) is the world's leading pharmaceutical branding agency, proud to be #1 in drug name approvals for 19 consecutive years. Our category-leading services include Name Strategy & Creation (USAN/INN, Brand, Clinical Trial, Program, and Line Extensions), Trademarks, Market Research, Name & Labeling Safety Research, and Visual Design. Job Description We are seeking an INN consultant/expert to join our Nonproprietary Division. This individual would represent the company as a consultant in th...

Job Title Executive Regulatory Affairs Business Unit R&D1 Regulatory Affairs Job Grade G12A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Job Description Compilation , review of dossier for US , EU , AU, C...

Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations. Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations. Preparation, reviewing, timely submission and coordination of implementation of labeling based on FDA notifications and/or RLD labeling updates. Coordination of labeling related activities with cross functional teams for timely launch of products. Regulatory submission and filings, coordinating final labeling implementation and maintaining labeling artworks using various softwares. Communication with third parties or p...

Job Title Executive Regulatory Affairs Business Unit R&D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Job Description Regulatory submission of new products, renewals, vari...

Role Overview: As a Senior Manager of Biostatistical Programming at Amgen, you will play a crucial role in leading an offshore team to ensure successful execution of end-to-end programming activities for products within or across therapeutic areas. You will collaborate with the Global Programming Lead to deliver milestone analysis and regulatory submission packages, while also contributing to programming strategies and process improvement initiatives. Your expertise in clinical trial operations, leadership skills, and technical proficiency will be key to driving the success of statistical programming study results and drug approval submission activities. Key Responsibilities: - Accountable f...

Job Summary LTM is responsible and accountable for deliverables of studies assigned to RCO unit, performing end to end study related onsite/ remote monitoring, quality data review, essential documents management for studies managed in-house with-in agreed timelines, budget and desired quality standards. LTM is expected to adhere to required standard operating procedures, regulatory requirements, ICH GCP and quality in compliance with Sun Procedural Documents. Area Of Responsibility Ensures clinical trials are conducted at assigned sites as per protocol, local regulatory requirements, ICH GCP, ensure data integrity, patient safety and trials are conducted as per ethical standards (declaration...

As a Lead Trial Manager (LTM) at the RCO unit, you will be responsible for the successful delivery of studies assigned to you. Your role will involve performing end-to-end study-related onsite and remote monitoring, ensuring quality data review, and managing essential documents for in-house studies within agreed timelines, budget, and quality standards. Your key responsibilities will include: - Ensuring that clinical trials are conducted at assigned sites in compliance with the protocol, local regulatory requirements, ICH GCP, and ethical standards - Acting as the primary communication point between SPIL and clinical trial sites for site management activities - Facilitating regulatory submis...

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the ...

Role Overview: As the Statistical Science Director at the organization, you will play a crucial leadership role in advancing the application of statistical science within the pharmaceutical industry. Your extensive experience in statistical methodology, project design, delivery, and interpretation will be instrumental in guiding various stages of product development. Your responsibilities will include leading statistical strategy for projects, contributing to regulatory submissions, and influencing internal governance decisions. The ideal candidate for this role is recognized externally as an expert in statistical methods and possesses the ability to guide complex analyses while mentoring ju...

Liaison with regulatory authorities/government bodies, coordination with customers/consultants - DGCI and India Regulatory bodies Provide regulatory advice to cross functional departments right from the development stage leading to a scientifically sound regulatory submission within committed project timelines Provide regulatory inputs and frame up strategy of regulatory submission during business development discussions with international customers and International Marketing Division Guidance to regulatory/quality team to perform their respective functions efficiently and accurately. Identify team member's capabilities to perform and assign additional responsibilities accordingly. Adopt th...

Role Overview: You will be joining Astellas Pharma Inc., a global pharmaceutical company committed to developing innovative therapies for patients worldwide. As a Central Monitor at Astellas Global Capability Centres, you will play a crucial role in supporting drug development projects and ensuring the implementation of Risk Based Quality Management (RBQM) strategies. Your responsibilities will include collaborating with cross-functional study teams, conducting central monitoring activities, and overseeing the documentation and resolution of findings. Your expertise and leadership will contribute to the success of clinical trials and the advancement of medical solutions for patients. Key Res...

As a candidate for this role, you will be responsible for the following key responsibilities: - Thorough knowledge of HPLC based analysis of recombinant proteins including RP-HPLC, SE-HPLC, and glycan analysis. - Independently design method development of proteins, qualification, transfer following ICH/USP/EP/IP guidelines. This includes writing and reviewing protocols, transfer plans, and reports. - Carry out day-to-day analytical work and collaborate with the Cell culture and downstream teams in Biotech R&D. - Set up product-related test/release specifications and analytical protocols for Biotech products. - Design in-house/outsource methods for Physico-chemical characterization of biologi...

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new sk...

Job Description Summary Prepare & Submit product application for all GEHC Medical Devices for India on regulatory portal, communicating business team updating the regulatory submission status & progress, updating regulatory submission details in Torus tool, Weekly updates on submission and registration status, Interacting with global PRA team for any new product submission and post approval submissions. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every diffe...

As an R&D Executive at PTC - SIGMA, you will be responsible for a wide range of activities related to documentation, product development, collaboration & coordination, and team training. Your primary responsibilities will include preparing various Technology Transfer documents such as LIF, PIF, PBOM, BOM for VAQ review, FBOM, and MFC. You will also be initiating AIF and Change control in the portal and handling SAP related activities including BOM loading, New SAP code generation, and Code extension. Additionally, you will be involved in LnB Issuance, PDR review, LnB and Project Files Archival, SOP preparation, review, and training, as well as Form 29, Form-11 application activities. In term...

The Affiliate Safety Representative (ASR) in India plays a crucial role in ensuring that all activities related to pharmacovigilance (PV) for Abbott EPD investigational and registered medicinal products under Abbott India Limited (AIL) and Abbott Healthcare Pvt Ltd (AHPL) are conducted in compliance with internal Abbott policies, procedures, and local regulatory requirements. The ASR is also responsible for overseeing PV activities in neighboring countries such as Nepal, Bhutan, Maldives, and Sri Lanka. Additionally, the ASR serves as the primary pharmacovigilance interface of Abbott EPD with local health authorities and represents pharmacovigilance internally within the Affiliate organizati...

The Assistant General Manager - Nasal Spray Formulation Development will play a crucial role in leading the development of innovative nasal spray formulations within the Research & Development (R&D) department of a Pharmaceuticals company. Reporting to the Head of R&D, you will be responsible for driving projects from concept to commercial scale-up, ensuring regulatory compliance and meeting quality standards. Your primary focus will be on designing, developing, and optimizing nasal spray drug products for global markets. Key Responsibilities: - Develop and technology transfer Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. - Condu...

Corporate Title: Assistant Vice President To comply with both US and Global regulations, the Financial Market Infrastructure (FMI) Operations team must ensure there are Contingency Strategy (CS) documents in place for all material relationships held with FMIs and Agent Banks, to support continued access to key services in a stress scenario. The CS document describes the actions which could be taken by the FMI and how the DB Group could respond, ahead of and during resolution. To determine which relationships require a CS, an annual global data collection is coordinated by the FMI Operations team, which drives a materiality assessment to determine the key relationships for the DB group. The c...

1) Review and compilation of ANDS Module 1 to Module 4 2) Review and compilation of SANDS 3) Review and compilation of labelling documents 4) Compilation and submission of applications using eCTD software

Key Responsibilities: Strong understanding of eCTD, NeeS, and ICH guidelines. Familiarity with Regulatory systems and Publishing tools. Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint. Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) Manage lifecycle submissions including variations, amendments, and renewals. Perform document-level publishing, hyperlinking, bookmarking, and validation. Conduct quality control checks to ensure submission readiness. Collaborate with cross-fun...

Reporting Structure Reports to Manager Key Roles/Responsibilities End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines. Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of ICSRs. Enter and/ or submit cases to applicable regulatory authority safety databases. Perform and monitor literature for company molecules. Maintain and update safety logs and safety files. Prepare and share compliance data with QPPV. Provide data for compliance representation/monthly in...