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Senior Manager, CMC Regulatory Affairs

Expired Job

Iconma, L.L.C. Raleigh , NC 27611

Posted 5 months ago

Senior Manager, CMC Regulatory Affairs

Location: Raleigh, NC

Duration: Fulltime

Job Description:

Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs) and agency communications (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific background.

  • Identifies CMC regulatory issues and communicates them to the CMC team to mitigate risk.

  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, with minimum 4-6 years of experience in the pharmaceutical industry

  • Knowledge and experience of CMC activity in medicine development and post approval management. Knowledge of health authority guidance and regulations.

  • Skills to drive and navigate project

  • Knowledge of CTD dossier (module 2.3 and 3).

  • Strategic business thinking

  • Global organizational awareness

  • Excellent written and verbal communication skills

  • Leading change/innovative thinker

  • Prepares original NDAs, MAAs and Growth Market dossiers ensuring that quality documents are prepared.

  • Tracks Module 3 leafs for global submissions.

  • Leads CMC authoring kick off meetings.

  • Interacts with and influences external stake holders.

  • Develops regulatory strategy.

Post Approval Projects

  • Prepares CMC content of post approval supplements and variations globally; annual reports, product renewals, notifications and change supplements.

  • Tracks Module 3 leaf changes made as a result of post approval activity and submissions.

  • Leads CMC authoring kick off meetings. Guides authors regarding the necessary Module 3 updates.

  • Interacts with and influences external stakeholders.

  • Evaluates proposed post approval changes and develops the regulatory strategy.

  • Maintains Agency Approved Module 3 dossiers globally.

Job Qualifications

  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, with minimum 4-6 years of experience in the pharmaceutical industry

  • Knowledge and experience of CMC activity in medicine development and post approval management. Knowledge of health authority guidance and regulations.

  • Skills to drive and navigate project

  • Knowledge of CTD dossier (module 2.3 and 3).

  • Strategic business thinking

  • Global organizational awareness

  • Excellent written and verbal communication skills

  • Leading change/innovative thinker

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Senior Manager, CMC Regulatory Affairs

Expired Job

Iconma, L.L.C.