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.
- 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