R&D Regulatory Safety Consultant

About Position:

We are looking for a Presales Consultant – R&D Regulatory/Safety with strong expertise in regulatory affairs, safety operations, compliance, and R&D governance. This role collaborates with Sales, Delivery, Regulatory SMEs, and Bid Management to develop effective solution proposals, including discovery, value articulation, demos, pricing, and executive presentations. You will translate complex regulatory and safety requirements into practical, high-value solutions for global Pharma and CRO clients.

- Role: R&D Regulatory Safety Consultant - Pharma Domain - Location: Pune, Bangalore, Hyderabad, Chennai - Experience: 15+ Years - Job Type: Full Time Employment

What You'll Do:

- Develop differentiated solutions and RFP/RFI responses—manage storyline, architecture, scope, and delivery; work with Bid Management to create competitive strategies, including pricing. - Provide leadership in Regulatory and Safety domains by translating business and compliance requirements into robust solutions across regulatory affairs, operations, pharmacovigilance, and safety analytics, ensuring effective compliance, automation, and readiness for audits and inspections. - Integrate Regulatory and Safety with R&D, highlighting compliant content flows and demonstrating business impact through end-to-end transformation. - Partner with Delivery to validate feasibility, effort, assumptions, and risk; ensure a clear trace from business requirements to solution components, cost models, and transition plans. - Enable deal orchestration— Contribute reusable assets (demos, playbooks, POVs) to improve win rate and sales velocity across the Pharma/CRO portfolio.

Expertise You'll Bring:

- Expertise in regulatory submissions, cross-functional workflows, global agency requirements, structured content, eCTD management, and product labelling operations. - Extensive pharmacovigilance experience in case processing, medical review, periodic reports, safety signals, compliance, risk evaluation. - Knowledge of GxP, data integrity, audit trails, inspection, and compliance documentation. - Regulatory Platforms: Veeva Vault RIM Suite (Submissions, Submissions Archive, Registrations),Liquent,EXTEDO,LorenzDocuBridge. - Safety Platforms: Argus, ArisGlobal LifeSphere Safety, PV intake automation tools, safety analytics platforms, and AI/ML use cases in signal detection. - Data, Analytics & Automation: BI dashboards for PV/regulatory KPIs, automation for case processing, automation in publishing/labeling, and content governance tools.

Benefits:

- Competitive salary and benefits package - Culture focused on talent development with quarterly growth opportunities and company-sponsored higher education and certifications - Opportunity to work with cutting-edge technologies - Employee engagement initiatives such as project parties, flexible work hours, and Long Service awards - Annual health check-ups - Insurance coverage: group term life, personal accident, and Mediclaim hospitalization for self, spouse, two children, and parents

Values-Driven, People-Centric & Inclusive Work Environment:

Persistent is dedicated to fostering diversity and inclusion in the workplace. We invite applications from all qualified individuals, including those with disabilities, and regardless of gender or gender preference. We welcome diverse candidates from all backgrounds.

- We support hybrid work and flexible hours to fit diverse lifestyles. - Our office is accessibility-friendly, with ergonomic setups and assistive technologies to support employees with physical disabilities. - If you are a person with disabilities and have specific requirements, please inform us during the application process or at any time during your employment

Let's unleash your full potential at Persistent

"Persistent is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind."