A new opportunity has arisen for a Regulatory Affairs Senior Manager at Opiant Pharmaceuticals, a specialty pharmaceutical company focused on addiction and drug overdose.

We are looking for a Regulatory Affairs Senior Manager to coordinate all regulatory activities and provide oversight in regulatory compliance of drug product design. Opiant has a developing pipeline, including a range of drug-device combination products based on nasal and injectable technologies.

Key Roles & Responsibilities:

  • Provide regulatory expertise and leadership.
  • Lead all aspects of regulatory for drug-device combination product development from early-stage clinical through to commercialization.
  • Regulatory expert on project teams.
  • Interpret regulatory policies and guidance and provide advice accordingly.
  • Prepare and review regulatory submission documents for devices, clinical trials, and marketing authorization applications.
  • Provide assistance and guidance to third-party contractors in developing drug-device combination products.
  • Interface with global regulatory authorities and notified bodies.
  • Develops and maintains a strong working knowledge of regulatory guidelines.
  • Build and maintain effective relationships with external stakeholders.

Job Requirements:

  • Significant regulatory affairs experience within US and EU regulations and procedures.
  • In-depth working knowledge of FDA regulations on drug-device combination products.
  • Working knowledge of the EU medical device submission requirements and the EU medical device regulation.
  • Bachelor’s degree equivalent or higher qualification within Pharmaceutical or relevant life science.
  • Ability to multitask and manage multiple deadlines.
  • Excellent verbal and written communication skills.
  • Self-motivated with the ability to work well autonomously

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