Associate Director, Regulatory Science
- Remote, United States
- Full-time
- Lead
- Posted 9 days ago
or apply from Claude / ChatGPT / Muse
Regulatory science lead for an oncology drug developer, remote, guiding clinical submissions and advising cross-functional study teams.
About the role
The role represents regulatory science on study and submission teams and gives advice on clinical development questions. Work includes planning submissions, spotting regulatory risk early and keeping timelines on track.
At a glance
- Pay
- Not stated in the posting
- Remote scope
- Remote, United States
- Seniority
- Lead
- Employment
- Full-time
- Skills
- Regulatory Affairs, EU CTR submissions, Oncology drug development, Regulatory submissions
- Posted
- 20 Oct 2026
- Last checked
- 29 Oct 2026
What you will do
- Plan, prepare and coordinate regulatory submissions with attention to quality and deadlines
- Is the regulatory science expert on cross-functional study and submission teams
- Run regulatory research to inform strategy, assess risk and propose mitigation
- Build and maintain processes and procedures, consulting senior staff when risks arise
What they look for
- Bachelor's degree in a relevant field, with an advanced degree desirable
- At least 9 years in pharma or biotech, including 5 or more in regulatory affairs
- Experience preparing large, complex submissions for health agency review and post-approval work
- Working knowledge of US FDA and EU EMA rules and guidance, plus EU CTR submissions
How Keywordise applies for you
Alex Demo
[email protected]
From your CV
Yes, fully remote
- Sent
- 09:41
- Attached
- Your tailored CV
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Claude
- In Claude, open Settings, then Connectors, and choose Add custom connector.
- Name it Keywordise and paste the connector URL.
- Click Connect, log in to Keywordise and approve. Then send the prompt in a new chat.
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- In ChatGPT, open Settings, then Connectors. On plans that need it, turn on developer mode first.
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- Log in to Keywordise and approve. Then send the prompt in a new chat.
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Muse
- Open Muse (muse.ai or the app) and send it the message below.
- If Muse asks how to sign in, answer OAuth. Open the sign-in link it sends, log in to Keywordise and approve.
- Send the prompt. Muse asks before it sends anything.
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.
Apply to Keywordise job q2iehg77a3Questions about this job
Can I do this job remotely, and from which countries?
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 in a relevant field, with an advanced degree desirable; at least 9 years in pharma or biotech, including 5 or more in regulatory affairs; experience preparing large, complex submissions for health agency review and post-approval work. Skills it names include Regulatory Affairs, EU CTR submissions, Oncology drug development, Regulatory submissions.
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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