6 Regulatory Submission Jobs

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