ParexelHiring

Regulatory Affairs Consultant, CMC Strategy (Biologics and Vaccines)

  • Remote, Canada
  • Senior
  • Posted 2 weeks ago
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In one line

CMC regulatory strategy role for biologics and vaccines, working inside one client program on US and EU submissions; remote.

About the role

Ownership covers CMC strategy across the product lifecycle, from variations and post-approval changes through authoring and reviewing Modules 1 to 3. The work sits in a dedicated client team, with room to act as a trusted advisor on submissions and compliance.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, Canada
Seniority
Senior
Skills
CMC regulatory affairs, Biologics, Vaccines, Modules 1-3, Dossier gap analysis, Lifecycle management
Posted
20 Oct 2026
Last checked
3 Nov 2026

What you will do

  • Shape CMC regulatory strategy for lifecycle work, including variations and post-approval changes
  • Write and review CMC documentation in Modules 1 to 3 for submissions worldwide
  • Lead global filings in the US, EU and other regions from planning to execution
  • Run dossier gap analyses and give clear strategic recommendations
  • Work with regulatory, quality, manufacturing and client stakeholders

What they look for

  • Experience in CMC regulatory affairs for biologics or vaccines
  • Track record with global submissions and lifecycle management
  • Ability to author and review Module 1 to 3 content to a high standard
  • Comfort working directly with client stakeholders in a program team

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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  3. Send the prompt. Muse asks before it sends anything.
Message for Muse
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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?

Yes. The posting lists Regulatory Affairs Consultant, CMC Strategy (Biologics and Vaccines) as a remote role for candidates in Canada.

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 in CMC regulatory affairs for biologics or vaccines; track record with global submissions and lifecycle management; ability to author and review Module 1 to 3 content to a high standard. Skills it names include CMC regulatory affairs, Biologics, Vaccines, Modules 1-3.

How do I apply with Keywordise AI?

Click Apply with Keywordise AI, create an account and upload your CV. Your CV and cover letter are written for this job from what you have really done, then Keywordise applies for you. Trial: 7 days, no card.

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