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Regulatory Affairs Specialist CMC at Adalvo

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At Adalvo, we pride ourselves on being more than just a company. We’re a team of passionate individuals committed to delivering high-quality products and services to our partners. With a culture that values positivity, speed, and precision, Adalvo is on a mission to stay consistently on target.

Responsibilities in the Role

As a Regulatory Affairs Specialist (CMC), you will play a vital role in securing and maintaining marketing authorizations in target markets. Your core responsibilities include:

  • Evaluating and assessing marketing authorization application dossiers.
  • Compiling dossiers for submission to regulatory authorities.
  • Supporting technical transfers and contributing to regulatory lifecycle management.
  • Compiling technical documentation related to medical devices.

Qualifications

To thrive in this role, candidates should meet the following criteria:

  • Hold a bachelor’s degree in science (e.g., Pharmacy, Pharmaceutical Technology, Chemistry).
  • Have a minimum of 4 years of experience in a similar role within the pharmaceutical industry.

Key Skills and Competencies

Success in this role requires a blend of technical expertise and personal attributes, including:

Well-organized and target-driven with a passion for achieving excellence.

Strong attention to detail and the ability to adapt quickly to changing requirements.

Excellent communication, organizational, and project management skills.

Analytical thinking and problem-solving capacity.

A proactive and enthusiastic attitude with a collaborative spirit.

Application Link

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