Dr. Priya Mehta

Regulatory Affairs

BioNex Therapeutics

Email Call

Next move: Send Priya the scheduled follow-up

Where things stand

Buying style: C · Conscientious

Last contacted

Jul 16, 2026 • 4:58 PM

6 days ago

You are here

Today

Jul 22, 2026

Next step

Aug 11, 2026

in 19 days

Offerings for Priya

Once BioNex Therapeutics is classified, the services relevant to Priya's role will appear here.

Classify BioNex Therapeutics and every offering that fits Priya's role shows up here — ready to pitch.

Classify BioNex Therapeutics now

LinkedIn Profile

20+ years leading regulatory strategy for complex biologics and small molecules across US, EU, and emerging markets. Led 12 successful NDA/MAA approvals. Former FDA reviewer.

Experience

VP Regulatory Affairs
BioNex Therapeutics · 2019 – Present
Leading global regulatory strategy for a pipeline of 8 biologics and 3 small molecules.
Director, Regulatory Affairs
Novartis · 2014 – 2019
Regulatory Reviewer
US FDA (CDER) · 2008 – 2014

Skills

Regulatory StrategyFDA SubmissionsCTD DossiersBiologicsCMCClinical RegulatoryEMACDSCO

Who else you know here

The other people you know at BioNex Therapeutics. Deals stall when they hang on one person — the more contacts you're talking to, the safer it is. Click anyone to open them.

Priya is your only contact at BioNex Therapeutics right now — that's risky. Find a second person (a peer or their manager) so the deal doesn't rest on one relationship.

Agent recommends

Your next best move

Send Priya the scheduled follow-up

A follow-up is due — draft the recap with a concrete next step.

How to engage

Inferred buying style: Conscientious — detail-driven & risk-averse

Evidence-led and precise. Trusts specifics, frameworks, and a clean track record.

Bring data, references, and exact frameworks (CTD, MDR, 21 CFR)

Be precise — name the agency and the standard

Show proof points and prior similar work

Avoid: Vague claims

Avoid: Overselling or hard closes

Pre-call brief

Priya — VP Regulatory Affairs at BioNex Therapeutics. A follow-up is due Aug 11, 2026. Recommended next move: Send Priya the scheduled follow-up.

RoleVP Regulatory Affairs.

StyleConscientious — detail-driven & risk-averse — Bring data, references, and exact frameworks (CTD, MDR, 21 CFR).

MomentumFollow-up due Aug 11, 2026.

ThreadingOnly mapped contact at the account — widen the thread to de-risk.

Recommended: Send Priya the scheduled follow-up

Pitch Sessions

5-Minute Pitch Script

Hi Dr. Mehta, I'm Suren Dheen from Freyr Solutions — I noticed your background includes time at FDA CDER before moving into industry, so I'll skip the basics and get straight to what I think matters for BioNex right now.

With your NDA submission coming up later this year and two compounds in Phase 2, you're entering the period where regulatory execution either accelerates or stalls your timeline. Freyr has completed over 5,000 regulatory submissions globally, and our team includes former FDA and EMA reviewers — people who know exactly what the agency expects to see.

Specifically for BioNex, I think two things are worth a conversation: first, our CTD dossier preparation service where we've consistently cut submission prep time by 30-40% for companies your size. Second, our Regulatory Intelligence service — given that you're working across FDA and EMA simultaneously, having automated monitoring across 120+ agencies in one place would remove a lot of manual tracking burden from your team.

I'm not here to sell you a contract today — I'd love 20 minutes with you and whoever owns the NDA prep to show you specifically how we've handled submissions for similar biologics pipelines. Would next week work?

Interaction History

In Progress
Jul 16, 2026 • 4:58 PM
Had intro call. She is interested in CTD dossier support. Sending proposal next week.
Follow-up Aug 11, 2026Logged by Suren Dheen