10 Regulatory Submission Jobs

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 biological products. - Coordinate with QC for the smooth implementation of new methods. - Maintain equipment logs and documentation in the lab. - Monitor and maintain stability of various products in Biotech. - Prepare lab-related documents, regulatory submission documents, and provide QC support (SOP, STP, COA, MOA, Specification). - Interpret data and write reports in support of regulatory submissions. - Review analytical data for in-process & stability related activities. Qualifications required for this role: - Strong knowledge of HPLC based analysis of recombinant proteins. - Experience in method development, qualification, and transfer following ICH/USP/EP/IP guidelines. - Good understanding of analytical work in a Biotech R&D setting. - Ability to design analytical protocols for Biotech products. - Knowledge of Physico-chemical characterization of biological products. - Proficiency in interpreting data and writing reports for regulatory submissions.,

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 skills and experiences that will propel your career to new heights. Making animals lives better makes life better - join our team today! Company Overview: 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. We're driven by our vision of Food and Companionship Enriching Life and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet, and our enterprise. 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 skills and experiences that will propel your career to new heights. Making animals lives better makes life better - join our team today! Your Role: Analyst - PV Case Processing As an analyst in PV Case Processing, you will be responsible for managing adverse event reports, ensuring data accuracy, and maintaining compliance with global pharmacovigilance regulations and timelines. The role involves data entry, assessing seriousness and causality, and ensuring the completeness and quality of cases for regulatory submission. Effective communication skills, knowledge of regulations, and the ability to manage multiple priorities are essential. The Analyst must demonstrate Elanco core values, adaptability, and commitment to high-quality standards in all tasks. Your Responsibilities: Responsible for data entry, seriousness assessment and causality assessment of adverse event reports in the PV database Identify issues in case processing that may result in a delay in submission and escalates issues to management as appropriate. Develop an understanding of pharmacovigilance regulations and comply with internal and external timelines for managing adverse events and product complaint case processing, and case submission processes as appropriate. Typical case processing activities include (but not limited to): Validation of data entry against source document(s) and call notes as appropriate. Assessment of adverse event reports for seriousness, reportabilities and causality including reason for assessment. Perform self-review of all data for completeness, correctness and quality. Ensuring that the case is considered complete, accurate, and ready for submission to appropriate regulatory authorities. Determine what, if any, follow-up information is needed Ensure to meet the expected productivity and quality standards. Active participation in team meetings. Perform other duties as assigned. What You Need to Succeed (minimum qualifications): Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience or Master's degree in Life Sciences related field with 0-2 years of pharmacovigilance experience. Strong stakeholder communication, Effective multitasking and adaptability, Regulatory and systems proficiency What will give you a competitive edge (preferred qualifications): Familiarity with veterinary PV and safety databases Excel skills (advanced excel, pivot tables, Power Query) and basic understanding of tools like Power BI or SQL for data handling. Exposure to E2B submissions and XML files adds value. Additional Information: Travel:No travel needed Location: IN, Bangalore - Hybrid Work Environment Don't meet every single requirementStudies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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 difference builds a healthier world. tex Job Description Roles & Responsibilities: Ensuring the accuracy and optimal presentation of information in submissions to regulatory authorities and internal presentations, and that they meet current best practice standards. Liaising with relevant personnel within GEHC to ensure appropriate, timely input is provided for submissions to regulatory authorities and that all legally mandated deadlines for submission are met. Providing administrative support to the regulatory processes, (i.e. compilation and dispatch of submissions, arranging payments to regulatory bodies). Acting as regulatory functional expert in computer-based support system in order to input, track and follow-up on information in the system. Basic Qualification Bachelor&aposs Degree in any specialization under Engineering with 0-1 years of experience. Desired Qualification Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills Inclusion And Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. Show more Show less

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 terms of product development, you will be conducting literature searches, monitoring raw material availability, aligning formulation development activities, preparing project presentations, loading products in stability studies, and analyzing stability data. You will also be responsible for preparing regulatory submission documents and ensuring compliance with SOPs during practical work. Collaboration and coordination with other departments such as ADL, PKG, RA, GDSO, and CQA will be crucial for the successful execution of day-to-day activities. Additionally, you will be expected to deliver presentations on assigned topics and share execution learnings within the team. Overall, as an R&D Executive at PTC - SIGMA, you will play a key role in driving the successful development and documentation of products, ensuring regulatory compliance, and fostering effective collaboration within the organization.,

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 organization. Key responsibilities of the ASR include: - Acting as the Pharmacovigilance Officer In-Charge (PvOI) on a 24/7/365 basis - Maintaining the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates - Conducting PV business continuity planning and notifying any business interruptions that may impact pharmacovigilance processes or regulatory compliance - Receiving, recording, and reconciling safety information - Conducting safety surveillance, including literature and health authority website screening, and preparing local periodic safety reports and Risk Management Plans - Submitting safety information to regulatory authorities - Providing basic PV training to local EPD staff - Managing PV records retention and archiving - Implementing out-of-office coverage for receiving and recording safety-relevant information - Maintaining the local PV product list - Ensuring PV compliance in local interventional studies and data collection schemes - Negotiating and implementing local pharmacovigilance agreements - Conducting due diligence for product acquisition or in-licensing - Providing local PV Compliance metrics and managing non-compliances - Coordinating PV audits and inspections at the Affiliate level - Ensuring vigilance compliance for various Abbott EPD products - Supporting in the preparation of Health Hazard Assessment/Medical Expert Statements - Acting as a Marshal for PV Self-Assessment Work Instruction and PV Representative for Global Clinical Programs - Reviewing and approving local PV training matrices - Collaborating with stakeholders to exchange PV-relevant information - Handling global projects The ASR is responsible for managing a team of direct reports and is accountable for the implementation and maintenance of a functional and compliant local PV system. The role requires expertise in PV, understanding of local PV regulations, attention to detail, computer literacy, strong English language skills, and effective communication and presentation abilities. Minimum qualifications for the role include: - 10+ years of PV experience in a pharmaceutical company - Understanding of local PV regulations - Attention to detail - Computer literacy (Windows, MS Office) - Good English language skills - Strong communication and presentation skills with internal and external stakeholders Ideally, candidates should hold a graduate degree in Medicine, Pharmacy, or equivalent qualification.,

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. - Conduct literature search reports for drug substances and products, design product development strategies, and propose different formulation strategies based on the review outcomes. - Guide executives in lab development batches, provide expert input into formulation and process studies, and ensure compliance with specifications. - Evaluate packaging material vendors, monitor stability studies, and prepare/review Technology Transfer documents. - Coordinate with internal stakeholders, follow GLP & GMP, participate in stability and validation batch manufacturing, and prepare PDR for regulatory submission. Qualifications & Skills: - M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or related field. - Specialization in drug delivery systems or formulation science preferred. Experience: - 8-10 years of formulation development experience, with a minimum of 5 years focused on nasal spray or inhalation formulations. - Proven experience in nasal spray product development from early-stage to commercial scale-up. Technical Expertise: - Strong understanding of nasal spray formulation techniques, drug-excipient interactions, and delivery systems. - Experience with device development and knowledge of regulatory requirements for nasal spray formulations. Project Management: - Strong project management skills, ability to manage multiple projects, work with cross-functional teams, and deliver results. Regulatory Knowledge: - Experience in preparing and reviewing regulatory submissions, familiarity with CMC requirements for nasal formulations. Leadership & Communication: - Ability to lead and develop a team, excellent communication and presentation skills for conveying complex scientific information. Problem-Solving & Innovation: - Strong analytical and problem-solving skills, ability to innovate and apply new technologies to improve drug delivery processes. Work Environment: - Primarily based at the R&D center with occasional travel to manufacturing sites, vendors, and regulatory meetings. Join us in this exciting role to contribute towards developing high-quality nasal spray formulations for global markets.,

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 creation/refresh of a CS involves being able to review and interpret global regulatory guidance, to ensure the CS is adapted to evolving requirements. The team also engage with Business, Operations, Treasury, Legal, and Risk Management functions to gather their feedback and input. Your key responsibilities Support the completion of the annual data gathering outreach, including data validation / review. Analyze and interpret regulatory guidance and enhance existing contingency strategies to meet regulatory requirements. Independently manage the review/creation of multiple CSs for FMIs / Agent Banks ensuring a high and consistent standard of quality. Effectively manage communication, feedback and approval from internal senior stakeholders. Perform quality and consistency reviews of contingency strategies. Provide support for the Team lead / process oversight and governance. Your skills and experience Excellent reading and writing skills, with ability to independently draft new documentation suitable for regulatory submission. Strong ability to scrutinise extensive documentation, review and interpret regulatory guidance, to incorporate to the CS. Analytical and communications skills; effectively host meetings with multiple stakeholder groups including senior management/external audiences. Confident data review, analysis and presentation (pivots/v-lookup/text functions/formulas/SharePoint/PowerPoint/Excel) with high and consistent attention to detail. Ability to prioritise and effectively manage workload across multiple workstreams, working within tight time frames, providing accurate updates, escalations and highlighting remedial actions. Desirable to have; Understanding of Living Wills / Recovery and Resolution Planning and other applicable regulations. Understanding of the operations and functions of clearing houses, central securities depositories, and payment systems. Understanding of securities & cash products. Previous operational (settlement and clearing) industry experience Team or process lead/management experience

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-functional teams including Regulatory Affairs, CMC, and Clinical. Stay updated with global regulatory guidelines (ICH, FDA, EMA). Detail-oriented with a collaborative mindset. Minimum Qualifications and Experience B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc. Minimum 4 to 8 years Preferred Qualifications/ Skills Proficiency in managing Regulatory eCTD Submission for all Global Markets. Good knowledge on eCTD Guidance and understanding validation criteria requirement. Strong communication and interpersonal skills. Experience with electronic submission (New Development Product Filings / LCM). Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously. High level of attention to detail and accuracy in document level publishing and submission compilation/validation. Ability to work collaboratively in a cross-functional team environment. Proficiency in using regulatory databases, information management systems, and other relevant software tools. Commitment to staying updated on regulatory changes and advancements in the field.

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 information system. Assist in responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities. Prepare for internal or external audits and inspections. Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities. Essential Qualification Bachelors/ Masters degree in Pharmacy Competencies Good communication and interpersonal skills, both written and verbal Ability to manage multiple concurrent tasks Proven ability to meet strict deadlines Ability to work independently and in a team environment Competent in use of desktop applications: Microsoft word, excel and PowerPoint