ErascaHiring

Exec Director/VP Regulatory Affairs

  • Remote, United States
  • Executive
  • Posted 7 days ago
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In one line

Regulatory leadership for an oncology biotech, guiding programs from pre-IND through approval; hybrid or fully remote in the US.

About the role

Regulatory strategy for assigned disease areas, from early filings to launch and lifecycle work. The role leads health authority interactions and keeps submissions accurate and on time.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Executive
Skills
Regulatory affairs, IND, CTA, NDA, ICH guidelines
Posted
22 Oct 2026
Last checked
28 Oct 2026

What you will do

  • Set and carry out global regulatory strategy for defined disease areas and programs.
  • Prepare and review filings such as IND, CTA, DSUR, NDA and briefing documents.
  • Lead meetings and talks with the FDA and regulators outside the US.
  • Advise business development and due diligence work from a regulatory angle.
  • Guide audits, inspections and outside regulatory vendors.

What they look for

  • Ten or more years in pharma or biotech regulatory affairs.
  • Expertise in global strategy from pre-IND through NDA and after approval.
  • Hands-on knowledge of US and EU rules and filings such as IND, CTA and NDA.
  • Familiarity with FDA and ICH guidelines.
  • A bachelor's degree, with an advanced degree preferred.

Nice to have

  • Experience with expedited designations such as Fast Track, Breakthrough Therapy or PRIME.

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Questions about this job

Can I do this job remotely, and from which countries?

Yes. The posting lists Exec Director/VP Regulatory Affairs as a remote role for candidates in the United States.

What does this job pay?

The posting does not state a salary, so there is no figure to quote.

What experience is needed?

It is an executive role. The posting asks for: ten or more years in pharma or biotech regulatory affairs; expertise in global strategy from pre-IND through NDA and after approval; hands-on knowledge of US and EU rules and filings such as IND, CTA and NDA. Skills it names include Regulatory affairs, IND, CTA, NDA.

How do I apply with Keywordise AI?

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