Regulatory Affairs Jobs in Bethesda (MD)
and maintain technical knowledge in product development and international regulatoryaffairs? If so, we’re hiring a Senior Director/ Director of RegulatoryAffairs!
About You:
- You have 12+ years or more relevant regulatoryaffairs experience.
- You possess...
Integrity
- Patient care
- Recruitment
- Scheduling
- Screening
- Research
- ICH/GCP
- SOPs
- Liaising with regulatory authorities
- Liaise with ethics committee
- Protocol navigation
- Regulatoryaffairs
- IRB submissions
Equal Opportunity/Affirmative...
patients.
Here’s What You’ll Do:
- Provide clinical and scientific leadership within the pharmacovigilance function.
- Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory...
Reporting Structure:
The Manager, Health Policy and RegulatoryAffairs reports to the Director, Health Policy and Practice Advocacy.
Qualifications
Bachelors’ degree and minimum 3 to 4 years of relevant experience - prior association...
Senior Director or Assistant Vice President, RegulatoryAffairs
March 11, 2024
POSITION SUMMARY
Position Senior Director or Assistant Vice President, RegulatoryAffairs
Organization Pharmaceutical Care Management Association (PCMA)
Location...
difficult situations diplomatically.
Have strong organizational skills and ability to manage several projects simultaneously to ensure nothing falls through the cracks.
Have experience synthesizing complex policy issues and/or regulatoryaffairs...
that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Senior Director/Director of RegulatoryAffairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal...
distilling complex policy issues and/or regulatoryaffairs at the federal or state level.
Requirements
Your day in this position may include:
Crafting narratives by distilling complex policy and regulatory information into tangible messaging for a variety...
- Collaborates with RegulatoryAffairs and Manufacturing to ensure regulatory compliance.
- Performs other duties as assigned.
Qualifications:
- Bachelors degree in a scientific discipline...
medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and RegulatoryAffairs...