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Director, Regulatory Affairs CMC

Director, Regulatory Affairs CMC

Job Title: Director, Regulatory Affairs CMC
Contract Type: Permanent
Location: Remote
Industry:
Start Date: ASAP
Contact Name: Jorge Rios
Contact Email: j.rios@sciproglobal.com
Job Published: January 25, 2021 18:17

Job Description

*Regulatory Consultancy - Director, Regulatory Affairs CMC - Remote*

Our Client, a consultancy firm specializing in drug, biologics and device regulatory affairs, is seeking a Director of Regulatory Affairs CMC for a full-time remote position!

 

About the Role:

  • Function as RACMC lead for assigned products and regions
  • Provide strategic RACMC interpretation and guidance to project teams from early development through post-approval
  • Develop and execute the regulatory strategy (CMC aspects) to support the lifecycle of assets; determine from a strategic and scientific perspective the content of relevant CMC sections (technical and/or procedural) of project/product specific documents submitted to regulatory agencies (e.g. NDA, MAA, INDs, IMPDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements

 

Qualification:

1) Strategy; from a CMC standpoint

2) Writing Experience; CMC Content

3) Global experience

4) Cross Functional experience

 

Interested in:

1) Type of experience: biologics, small molecules, vaccines etc: this will decide which program they will work on

2) Submission/phase experience

 

Ideally: Opthalmology