Position Summary:

The Safety Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.

 Essential functions of the job include but are not limited to:

• Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports
• Maintain various spreadsheets, including but not limited to distribution/submission trackers
• Generate final clinical trial regulatory reports (e.g., CIOMS I, MedWatch 3500A, XML) from the global safety database for distribution/submission
• Prepare and distribute final submission documents, including Investigator Safety Letter
• Perform case closure and electronic filing of SAE related documentation
• Complete expedited report deviations which includes initiation, investigation, extension requests, and CAPAs, as appropriate
• Perform SAE reconciliation and send queries, as appropriate
• Reconcile and send SUSAR Gap Packs
• Maintain and update expedited email distribution lists
• Reconcile compliance metrics
• Support generation of overall distribution/submission compliance metrics
• Monitor regulatory intelligence databases for regulation updates and provides country specific reporting information to support the development of Safety Reporting Plans
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
• Attends Department meetings

Qualifications:

Minimum Required:

• Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
• Knowledge of the ARGUS Safety Database
• Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
• Experience with EMA EudraVigilance, UK MHRA and other recognised reporting portals
• BA/BS preferred

Position Summary:

The Safety Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.

 Essential functions of the job include but are not limited to:

• Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports
• Maintain various spreadsheets, including but not limited to distribution/submission trackers
• Generate final clinical trial regulatory reports (e.g., CIOMS I, MedWatch 3500A, XML) from the global safety database for distribution/submission
• Prepare and distribute final submission documents, including Investigator Safety Letter
• Perform case closure and electronic filing of SAE related documentation
• Complete expedited report deviations which includes initiation, investigation, extension requests, and CAPAs, as appropriate
• Perform SAE reconciliation and send queries, as appropriate
• Reconcile and send SUSAR Gap Packs
• Maintain and update expedited email distribution lists
• Reconcile compliance metrics
• Support generation of overall distribution/submission compliance metrics
• Monitor regulatory intelligence databases for regulation updates and provides country specific reporting information to support the development of Safety Reporting Plans
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
• Attends Department meetings

Qualifications:

Minimum Required:

• Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
• Knowledge of the ARGUS Safety Database
• Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
• Experience with EMA EudraVigilance, UK MHRA and other recognised reporting portals
• BA/BS preferred

POSITION OVERVIEW:

The Global Regulatory Lead Partner supports Global Regulatory Leads in assigned therapeutic areas and serves as the accountable global regulatory point of contact for designated products. The individual provides regulatory leadership for life‑cycle management, maintenance of established products, and execution of global regulatory submissions. This role drives results through regulatory science expertise, strong communication, and analytical capabilities, ensuring high‑quality regulatory strategies and deliverables for assigned products.

WORK LOCATION:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• Ensure maintenance of global registrations for assigned products, including US and EU markets.
• Lead and execute regulatory activities supporting life‑cycle management, including submission strategy development, timeline definition, prioritization, assembly review, and identification of regulatory risks/challenges.
• Manage regulatory agency communications and submissions, including responses to agency questions, labeling negotiations, updates, and periodic reports.
• Coordinate SMEs to develop response strategies and author/review responses to health authority requests.
• Support labeling discussions, updates, and filings across CCDS, USPI, SmPC, and country‑specific labels.
• Provide regulatory input for annual reports, renewal applications, and aggregate safety reports (e.g., PSURs, PADERs).
• Conduct regulatory review for tender bid applications and assess country requests for registration deletions.
• Support preparation of ancillary documents required for product registrations in global markets.
• Follow through on agency commitments and ensure timely, high‑quality regulatory deliverables.
• Conduct research and review of US, EU, and other relevant regulatory guidelines, precedence, and competitive intelligence to inform regulatory strategy.
• Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, and other functional partners to ensure alignment and execution of regulatory strategy.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor's degree or higher in a relevant field such as pharmaceuticals, chemistry, or regulatory affairs.

Experience:

• 5+ years of experience in regulatory affairs and/or regulatory framework of major health authorities
• Experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics. Has sufficient regulatory knowledge to integrate inputs from other countries/regions to develop a global strategy and can develop and lead execution of holistic regulatory strategy while considering risk/opportunity, timeline, resource.
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Understands scientific and clinical data sufficiently to ask questions and make suggestions about cross-functional topics to influence overall development strategy and to assess regulatory implications and develop regulatory strategy.
• Regulatory experience with pre and post approval lifecycle management, interactions with Health Authorities, leading cross-functional regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
• Strong business acumen and ability to make sound decisions that contribute positively to the business.
• Strong strategic skills and the ability to balance short-term needs with long-term vision.
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.

Skills and Attributes:

• Excellent written and verbal communication skills.
• Strong negotiating skills and ability to think creatively and develop innovative solutions.
• Strong organizational and project management abilities.
• Strong analytical skills with high attention to detail.
• Understanding of regulatory filing requirements.
• Knowledge of ICH guidance and routine regulatory maintenance requirements.
• Ability to manage multiple priorities and work independently in a fast-paced environment.
• Proactive, detail-oriented, and self-motivated with a strong work ethic.

Position Overview:  

As a Staff Software Engineer at Diligent, you’ll create robust, scalable, and secure microservices that power our SaaS platform for governance. You’ll leverage AWS (serverless or migrations) with TypeScript, own services end-to-end (code, deployment, monitoring), drive architecture discussions, and regularly demo to the department. A critical part of this role is shaping our AI strategy: you’ll lead design decisions, embed AI responsibly into systems, and mentor teams on AI capabilities, safety, and governance. 

Key Responsibilities: 

• Champion the design and delivery of secure, high-performance microservices on AWS, driving architecture decisions and empowering team members through mentorship. 

• Set technical direction across multiple teams, spotting system pain points and proposing improvements. 

• Pioneer AI-driven solutions by advising on model capabilities, crafting effective prompt strategies, and embedding governance and monitoring into development workflows. 

• Partner with Product, Security, and DevOps to shape technical roadmaps, ensure compliance, and seamlessly integrate AI features that deliver real business value. 

• Continuously elevate our toolkit by evaluating and piloting cutting-edge technologies (including AI toolchains), optimizing for performance, cost efficiency, and developer productivity. 

• Own projects end-to-end—from ideation and prototyping to deployment, monitoring, and iteration—ensuring resilient, maintainable systems and top-notch code quality. 

• Mentor engineers in best practices and AI-augmented workflows, fostering a culture of experimentation, learning, and ethical AI adoption. 

• Stay ahead of emerging AI trends and regulations, proactively adapting designs and practices to meet evolving standards and steer future innovation. 

Required Experience/Skills  

• 7–10 years delivering secure, scalable applications in agile environments. 

• Understanding of model architectures (e.g., transformer vs. retrieval-augmented), bias and safety concerns, prompt engineering, and proven experience shaping AI strategy and mentoring teams on responsible AI use. Ability to architect AI systems with embedded monitoring and governance. 

• Design and review scalable, high-performance system architectures, APIs, and data models, while writing high-quality, testable code in Node.js, React, and TypeScript/JavaScript, including reusable libraries and frameworks. 

• Lead end-to-end DevOps and platform engineering, including CI/CD pipeline design with strong guardrails, infrastructure-as-code and modern deployment strategies, cloud observability and incident response, and cost-aware architecture and capacity planning across AWS, Azure, and GCP 

• Integrates security best practices (IAM, secrets management) into all work, including AI components, and embeds bias/privacy checks in delivery pipelines. 

• Strong communication of technical and AI-related concepts to diverse stakeholders; proven ability to lead projects, influence engineering culture, and mentor peers in AI-augmented workflows. 

• Degree in Computer Science, Engineering, Mathematics, or equivalent experience. 

 *** Only Bangalore candidates may apply