Spyre TherapeuticsHiring

Director, Regulatory Affairs

  • Remote, United States
  • Lead
  • Posted 5 days ago
Apply with Keywordise AI

or apply from Claude / ChatGPT / Muse

In one line

Regulatory leadership role at a clinical-stage biotech, initially focused on an IBD program, leading global submissions and health authority meetings.

About the role

Owning regulatory strategy for one or more drug candidates, from first IND and clinical trial applications through meetings with the FDA, EMA and other agencies. The role also feeds regulatory thinking into preclinical, CMC and clinical plans.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Lead
Skills
Regulatory affairs, FDA, EMA, PMDA, Regulatory strategy
Posted
30 Oct 2026
Last checked
2 Nov 2026

What you will do

  • Plan and prepare health authority meetings, including briefing materials
  • Prepare, review and submit dossiers to the FDA, EMA, PMDA and others
  • Track regulatory changes and advise the company on expectations and risks
  • Work with preclinical, clinical, technical operations, legal and quality teams

What they look for

  • Bachelor's degree with 8 to 10 years in pharmaceutical regulatory affairs or a related field
  • Experience leading INDs and clinical trial applications
  • Familiarity with FDA and EMA meeting processes
  • Strong communication with agencies and cross-functional teams

How Keywordise applies for you

  1. 1Upload your CVAdd your CV once. It takes about a minute.
  2. 2Tailored to this jobKeywordise writes a CV and a cover letter for this job from your real experience.
  3. 3The form fills itselfName, email, experience and screening questions, field by field.
  4. 4Application sentYou get a receipt and follow it in your dashboard.

Apply with Keywordise AI7-day free trial, no card.

Apply from your AI assistant

Connect Keywordise to your assistant once, then send it the prompt. It applies for you.

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
https://keywordise.com/mcp

Disconnect any time in your Keywordise settings.

ChatGPT

  1. In ChatGPT, open Settings, then Connectors. On plans that need it, turn on developer mode first.
  2. Add a new connector with the connector URL and choose OAuth. Leave the client ID and secret empty.
  3. Log in to Keywordise and approve. Then send the prompt in a new chat.
Connector URL
https://keywordise.com/mcp

Disconnect any time in your Keywordise settings.

Muse

  1. Open Muse (muse.ai or the app) and send it the message below.
  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
Apply to Keywordise job 4ua7rtva3d
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 lead role. The posting asks for: bachelor's degree with 8 to 10 years in pharmaceutical regulatory affairs or a related field; experience leading INDs and clinical trial applications; familiarity with FDA and EMA meeting processes. Skills it names include Regulatory affairs, FDA, EMA, PMDA.

How do I apply with Keywordise AI?

Select Apply with Keywordise AI, sign up and upload your CV. Keywordise writes a CV and a cover letter for this job from your real experience and applies for you. The 7-day free trial needs no card.

More remote science and research jobs

All remote science and research jobs
Spyre TherapeuticsRemote, United States
Apply with Keywordise AI