Associate Director / Director Regulatory Intelligence Delivery

Infodesk; New York (NY); A distancia; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Infodesk is seeking a hands-on Regulatory Intelligence professional to deliver curated regulatory updates for pharma/biotech clients. You will own the delivery lifecycle from scoping to final QA, partnering with sales, analysts and AI capabilities.

The role emphasizes practical expertise over management oversight, with strong focus on accuracy and customer value. You will lead methodology development, shape feeds, and run projects end-to-end, ensuring timely, well-sourced outputs for diverse

Formación

• 6–8 years in pharma/biotech regulatory intelligence or regulatory strategy.
• Fluency in major regulatory sources (FDA, EMA, MHRA, Health Canada, PMDA).
• Hands-on with sources, feeds and outputs; strong QA capabilities.

Responsabilidades

• Scope customer coverage and build coverage plans with cross-functional teams.
• Define and translate customer needs into clear feed specifications.
• Brief and guide Information Strategy team on search strategies and AI prompts.
• Review and sign off on feed accuracy and relevance before go-live.
• Curate feeds, bulletins, alerts, and surveillance with analysts and AI.
• Support sales with domain input on RFPs, demos, and scoping discussions.

Conocimientos

Regulatory intelligence

Pharma/biotech

Stakeholder engagement

Quality assurance

AI prompts

Project management

Attention to detail

Independent

GxP awareness

Communication

Educación

Bachelor’s in science

Regulatory affairs certification

Herramientas

Regulatory platforms

AI prompt tools

Descripción del empleo

This role offers a remote work option. Candidates based in the EST time zone are preferred, as they will be working closely with other Infodesk team members across different locations.

Role overview:

This is a hands‑on strategic regulatory intelligence delivery and execution role. You will scope, shape and deliver curated regulatory intelligence for pharma, biotech and medical device customers, and you’ll lead the delivery team by working alongside them, not by supervising from a distance.

We prefer candidates in the EST time zone, as they will work closely with other Infodesk team members across

This Role

You’re self‑starter from a true regulatory intelligence background and want to be hands‑on with the sources, feeds and outputs. You’ll own the quality of what the team delivers, lead methodology development, and carry your own share of customer builds. You’ll run projects from first scope to final QA, without waiting for a roadmap or daily direction.

We don’t want a manager to review other people’s output; we want a strong practitioner to join the team.

About the Role:

The team transforms raw regulatory updates, news and scientific sources into targeted intelligence that each customer can act on. Our Regulatory Intelligence professionals sit at the intersection of our sales, analyst and AI capabilities.

Their work spans the full end‑to‑end process

• Scope the right coverage for a new or existing customer, with sales and internal teams
• Shape the regulatory intelligence feeds: define the required outputs and sources, and partner with Infodesk’s Information Strategy team to build search strategies and agentic AI prompts.
• Deliver curated regulatory intelligence (bulletins, alerts and surveillance) with analysts and AI

What you will do:

Scope customer coverage.

Turn a customer’s pipeline, therapeutic areas and regulatory obligations into a complete coverage plan.

• Run scoping sessions with Account Executives, Account Managers and internal teams
• Build and maintain client‑facing scoping workbooks: source maps and coverage matrices
• Identify and validate the right regulatory, news and scientific sources for each brief
• Collaborate and partner with other customer operation departments to deliver value to customers

Brief and direct the feeds.

You define what each customer needs, then build it in collaboration with Infodesk’s Information Strategy Team;

• Translate each customer’s needs into a clear specification of the intelligence and outputs required
• Brief and advise Infodesk's Information Strategy team as they build the search strategies and agentic AI prompts
• Review, test and sign off each feed’s accuracy and relevance before go‑live

Deliver targeted intelligence:

Own the quality of what reaches the customer.

• Curate and QA feeds, bulletins, alerts and surveillance outputs with analysts and AI
• Handle surveillance briefs across FDA, EMA/national authorities, MHRA, PMDA, NMPA, Health Canada, Swiss medic, ANVISA and TGA, plus other priority markets
• Define and enforce content SLAs: update latency after a regulatory change, versioning, source attribution and customer change notifications
• Govern AI‑assisted content: what can be machine‑extracted, what needs qualified human verification, and how provenance is recorded
• Own the production schedule and set up the standard processes that keep intelligence delivery efficient and accurate
• Review completed projects to identify efficiency gains and apply them to future work
• Work in partnership with sales, and with delivery, product and customer success, to turn recurring needs into product improvements
• Support sales with credible domain input on RFPs, demos and late‑stage deals, including rapid scope‑and‑pricing consultation pre‑sales

What you will bring:

• A solid regulatory intelligence background in pharma or biotech; you have done the work, not just managed people who do.
• Typically, 6 to 8 years in pharma or biotech, focused on regulatory intelligence or regulatory strategy.
• Fluency in the regulatory landscape and its major sources (FDA, EMA, MHRA, Health Canada, PMDA), and how obligations map to coverage.
• Working knowledge of GxP frameworks and pharmacovigilance
• Enough technical fluency to brief and quality‑check search strategies and AI prompts, and to tell strong feed logic from weak.
• A track record of translating stakeholder needs into scoped, deliverable feeds intelligence.
• Strong QA instincts and the judgement to separate signal from noise in regulatory content
• A self‑starter who would rather be hands‑on with tools and data than delegate, taking pride in the final output.
• An attention to detail that results in high‑quality customer deliverables without requiring oversight.
• Independent: you build the roadmap and close workflow gaps rather than waiting to be told
• A degree in a scientific or healthcare discipline, or equivalent hands‑on experience.
• Familiarity with regulatory intelligence platforms, alerting or intelligence tools, and workflow architecture.
• Exposure to AI classification, prompt engineering, or data labelling and validation
• Familiarity with regulatory data and interoperability standards (IDMP/SPOR, eCTD, structured product labelling/ePI, CTIS)
• Awareness of software‑quality and data‑integrity regimes (21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+)
• A track record of scaling production capacity through smart workflow design.
• Active involvement in RAPS, TOPRA, DIA or comparable professional organizations.