Description
Senior Associate / Associate Regulatory Affairs CMCA pharmaceutical company in the Novato, CA area is looking fora Senior Regulatory Affairs Associate to join their team. The Regulatory Affairs Associate is responsible for the coordination and preparation of a variety of global regulatory submissions for commercial biologic products.
Senior Regulatory Affairs Associate Responsibilities:
- Coordinate the preparation and submission of US and International regulatory CMC submissions
- Develop and/or review regulatory documents to ensure quality submissions
- Create timelines and track deliverables to ensure on-time submissions
- Proactively identify issues and suggest appropriate regulatory strategies to mitigate risks
- Ensure consistent and appropriate communication within the department and with other functional areas
- Interface with global Regulatory partners, internal cross functional teams, and consultants
- Assist in the preparation for meetings with global regulatory authorities
- Attend relevant functional area and project team meetings
Senior Regulatory Affairs Associate Requirements:
- Experience in a regulated biotechnology or pharmaceutical environment; 1 year in Regulatory Affairs or 2 years in a related function such as Process Development, Quality or Formulation
- General understanding of global drug development regulations and guidelines
- Outstanding interpersonal and effective task planning / coordination skills
- Strong verbal and written communication skills, ability to multi task
- Proficient with computer and standard software programs
- Excellent attention to detail
- Bright, ambitious, and self-starter
- Strong teamwork, negotiation, and influencing skills a plus
If you are interested in this position, please respond to this job posting ASAP with an updated version of your resume.
To find out more about Real please visit www.realstaffing.com