CMC Regulatory Affairs

CMC, Device/Instrument
Contract W2, Contract Independent, Contract Corp-To-Corp, 30 Months
Depends on Experience

Job Description

Job Title: CMC Regulatory Affairs

Location: JFK Parkway, NJ

Duration: Long term

 

Required Qualifications:

  • Strong experience in CMC requirements for small molecule/biologic products.
  • Post approval regulatory CMC experience, at least 5 years
  • Device/Instrument experience
  • Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
  • Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
  • Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
  • Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
  • Demonstrated effective leadership, communication, interpersonal and negotiating skills.
  • Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.

 

 

Thanks,

Kiran Veeraboina | Techno-Comp Inc.,

Phx 104

Dice Id : technonj
Position Id : KV_CMC
Originally Posted : 7 months ago
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