ParexelHiring

U.S. Regulatory Strategist

  • Remote, United States
  • Senior
  • Posted 2 weeks ago
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In one line

Remote regulatory role focused on U.S. strategy for vaccines and biologics, from early development through approval and after.

About the role

Remote position on a regulatory team working with global and cross-functional colleagues. Success means timely, compliant FDA submissions and clear strategy from planning to post-approval.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Senior
Skills
FDA regulations, IND, Regulatory strategy, Labeling
Posted
20 Oct 2026
Last checked
3 Nov 2026

What you will do

  • Build and carry out U.S. regulatory plans that fit global development and lifecycle goals
  • Handle FDA meetings, answer agency questions and track commitments
  • Prepare and review IND, NDA, BLA and supplement submissions
  • Keep labeling and lifecycle work compliant and share regulatory intelligence

What they look for

  • Experience with U.S. regulatory strategy for vaccines or biologics
  • Working knowledge of FDA requirements and submission processes
  • Ability to work with global regulatory and cross-functional teams

How Keywordise applies for you

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ClaudeConnectorChatGPTConnectorMuseby Meta

Claude

  1. In Claude, open Settings, then Connectors, and choose Add custom connector.
  2. Name it Keywordise and paste the connector URL.
  3. Click Connect, log in to Keywordise and approve. Then send the prompt in a new chat.
Connector URL
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ChatGPT

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Connector URL
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Muse

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  2. If Muse asks how to sign in, answer OAuth. Open the sign-in link it sends, log in to Keywordise and approve.
  3. Send the prompt. Muse asks before it sends anything.
Message for Muse
Add a custom connector called Keywordise. It is a remote MCP server at https://keywordise.com/mcp and uses OAuth. Give me the sign-in link.

Muse is available in the US only for now.

Prompt
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How to connect

Questions about this job

Is this a remote job, and where can I work from?

The posting lists it as remote for people in the United States.

What does this job pay?

No pay range is stated in the posting.

What experience is needed?

It is a senior role. The posting asks for: experience with U.S. regulatory strategy for vaccines or biologics; working knowledge of FDA requirements and submission processes; ability to work with global regulatory and cross-functional teams. Skills it names include FDA regulations, IND, Regulatory strategy, Labeling.

How do I apply with Keywordise AI?

Press the Apply with Keywordise AI button and add your CV. Keywordise tailors your CV and cover letter to this posting and sends the application for you, with a free 7-day trial and no card.

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