About Infodesk: www.infodesk.com

Infodesk is the enterprise intelligence SaaS solution that transforms intelligence into action.

We are forging a new market category: Intelligence Activation. Intelligence activation is the next evolution beyond business and market intelligence. It’s the process of turning information into action by embedding validated, decision-ready insights directly into the workflows where outcomes happen.

Infodesk helps teams identify what matters most, when it matters most, embed insights into workflows and stay prepared for anything, with full traceability and design optimized for complex, high-pressure environments. Founded in 1999, for more than twenty five years Infodesk has supported regulatory, compliance and strategic intelligence teams in complex, highly regulated industries such as life sciences.

Responsibilities

- Ensure completion of regulatory projects for InfoDesk’s customers in line with customer scope
- Work directly with InfoDesk i nte rn al s take hol de rs establisha nd e n f or ce scope of work and enable InfoDesk’s teams to fulfill services according to scope
- Research publiclyavailable websites from Regulatory Authorities and other relevant websites to identify and manage the information strategy process.
- Create searchesand apply standard“search logic” (including Boolean) to find certain websites that provide information on applicable laws and regulations.
- Evaluate applicable laws and regulations to determine impacton company and client activities
- Identify and interpret relevantregulatory guidelines, as they relate to InfoDeskclient projects




- Advise others on regulatory and compliance matters,as they relate to InfoDeskclient projects
- Explain regulations, policies, or procedures, as they relate to Infodesk stakeholders
- Coordinate regulatory documentation activities, in accordance to client projectscopes
- Provide technical review of data or reports
- Maintain data in information systems or databases
- Ability to navigate the Web and tools to consume content,like RSS, Google Alerts etc.

Must have:

- BA/BS in scientific/engineering/healthcare discipline, Masters, PharmD or Ph.D preferred
- 4-5 yrs in the Pharmaceutical Industryor regulatory strategyor similar training/ experience
- Strong knowledgeof current NorthAmerica and EU regulations, and familiarity with international regulations.
- Knowledge of and broad experience with regulatory procedures and legislation for drug/device development (specifically GxPs), product registration, line extension and license maintenance (US, CA & EU required).
- Understanding of regulatory controls and marketing pathways of INDs/IDEs/BLAs/NDAs/510(k)s/PMAs, marketing applications and other regulatory submissions and pathways (orphan drug, PRIME, IRP etc)
- Ability to manage complexprojects and timelinesin a multinational/multiculturalteam workplace

Preferred Skills:

- Regulatory Affairs Certification
- Past experience includes any of the following: review of product promotional materials, labeling (including changemonitoring), batch records,specification sheets, or test methods for compliance with applicable regulations and policies.
- Knowledge and experience in drugs, biologics, devices or combination products.

📌 Associate Delivery Analyst – Life Science & Regulatory (Vadodara)
🏢 InfoDesk
📍 Vadodara