, User fee staff, drug listing and Board of Pharmacies for state licensing submissions. Provide regulatory guidance to R..., submission, and monitoring of PLAIR activities, prior to new product launch Manage regulatory correspondence mainly to CDER, FDA...
in development of Regulatory CMC strategy in support of submissions of clinical trial applications and marketing applications.... A good understanding of Regulatory CMC requirements for clinical trial applications and marketing applications. Knowledge...
. Job Description The Manager, Global MDR Submission is responsible for managing Market Quality- COE MDR team for the regulatory assessment... and submission of Medical Device Reports to the FDA and assisting with submissions to other regulatory agencies worldwide...
. Job Description The Manager, Global MDR Submission is responsible for managing Market Quality- COE MDR team for the regulatory assessment... and submission of Medical Device Reports to the FDA and assisting with submissions to other regulatory agencies worldwide...
Job Title: Sr. Director, Regulatory Affairs Job Location: Boulder, CO, USA Job Location Type: Remote Job Contract... Type: Full-time Job Seniority Level: Director Enveda is looking for a Sr. Director, Regulatory Affairs to join our team...
, medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory...Description Senior Director of Regulatory Affairs Corporate Statement Nephron Pharmaceuticals Corporation...
and submissions for Implantable and Absorbable devices. Under the mentorship of the Senior Manager of Regulatory Affairs... Senior Manager of Regulatory Affairs, they are responsible for the development of complex global regulatory strategies...
for clinical development and commercialization. You should bring both a track record of successful regulatory submissions... groups and Regulatory Affairs department to plan and author high quality regulatory submissions to health authorities...
) to receive an alert: × Select how often (in days) to receive an alert: Specialist - Regulatory Affairs - Labeling... Facility: Reg Affairs & Safety Pharmacovigilance Location: Plainsboro, NJ, US About the Department The Clinical...
About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse... Labeling Specialist supports the development of labeling activities for all regulatory submissions. This individual...
, Regulatory Affairs is responsible for successful completion of complex regulatory projects such as: pre-submissions, IDE... Manages team of regulatory and clinical professionals at the Specialist or Manager levels Establishes and executes regulatory...
Clinical Research Regulatory Affairs area and program specialist(s) in accordance with all applicable institutional, state... all functions of the Clinical Research Regulatory Affairs team with minimal input and supervision from the Research Integrity...
Clinical Research Regulatory Affairs area and program specialist(s) in accordance with all applicable institutional, state... all functions of the Clinical Research Regulatory Affairs team with minimal input and supervision from the Research Integrity...
continuous improvement initiatives. You will partner with Clinical Affairs management and direct reports to develop and execute... clinical studies. This will include writing and/or reviewing assigned protocols in consultation with Clinical Affairs...
clinical trials by the medical affairs organization (non-regulatory label directed programs). This role requires a manager... with expertise in industry sponsored clinical research & global medical affairs,and have good cross-functional team management. The...
-regulatory label directed programs). This role requires a manager with expertise in industry sponsored clinical research & global... Studies will oversee the execution of a program of sponsored clinical trials by the medical affairs organization (non...
with business with business development strategies. Lead medical affairs team and initiatives related to regulatory submissions... of experience in regulatory and quality-related medical affairs activities, including clinical evaluation and post-market...
with business with business development strategies. Lead medical affairs team and initiatives related to regulatory submissions... of experience in regulatory and quality-related medical affairs activities, including clinical evaluation and post-market...
strategies. Lead medical affairs team and initiatives related to regulatory submissions, clinical evaluations, post-market...Work Flexibility: Remote Stryker is hiring a Senior Manager, Medical Affairs, this position is Remote, supporting...
in our office three days per week on average. The Sr. Manager, Regulatory CMC, is responsible for contributing to/assisting... molecules therapeutics worldwide. Coordinates global CMC regulatory activities necessary to conduct clinical trials, achieve...