for diversity, working mothers, female executives, and scientists The Opportunity We are seeking a Regulatory Affairs Manager... Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed...
activities of the Government Regulatory Affairs department. Assists with local regulatory, franchising and public policy matters... every day. If you share in our passion for teamwork, our vision to revolutionize industries and our goal to lead the future...
will oversee the day-to-day activities for a team of Regulatory Affairs Specialists. An individual in this role will partner... of Regulatory Affairs Specialists in regulatory requirements, project team support, and creative approaches to new devices...
, we recognize that our differences strengthen us. The Regulatory Affairs team at Fresh plays a crucial role in ensuring... decision-making, shaping the future of Fresh with every regulatory milestone. The Regulatory Affairs team at Fresh plays...
even with challenging customers. Support the US Regulatory Affairs Drug Product Lead in Tampa. Perform other duties as required. Key... improve the world. And that’s the kind of work we want to be part of. Key Responsibilities: Provide regulatory & strategic...
products. Lead the regulatory review of promotional materials related to marketed products, disease state information... Standard Operating Procedures and internal guidance documents for related activities and provide training to Regulatory Affairs...
Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs... in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline. 5-7 years of experience in regulatory affairs...
Responsibilities: The Sr GPRM works under limited supervision of the regulatory affairs (RA) program lead to develop... and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned...
-market RA Manager: Provides regulatory oversight on all aspects of post-market requirements, including but not limited to the...): Acts as the regulatory lead on the risk analysis worksheet (RAW) reviews for on-market product to identify potentially...
from senior labeling management: Marketed products and Late Stage Development Projects - actively lead the execution... activities, including development/improvement of training and coaching tools Lead and/or participate on internal working groups...
at Baxter Regulatory Portfolio Lead responsible for managing the regulatory aspects of complex development programs... will be responsible for direct interactions with US and EU regulatory bodies (including CE Marking). What you'll be doing Provide...
and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet..., submission, and monitoring of PLAIR activities, prior to new product launch Manage regulatory correspondence mainly to CDER, FDA...
and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet..., submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER...
and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet..., submission, and monitoring of PLAIR activities, prior to new product launch Manage regulatory correspondence mainly to CDER, FDA...
. Manager, Medical Quality & Compliance Work Schedule: Mon - Fri, Business Hours Hybrid role: 50% in office per two week... period Manager of Medical Quality Assurance and Compliance will play an important role in the day-to-day engagement quality...
Description Senior Director of Regulatory Affairs Corporate Statement Nephron Pharmaceuticals Corporation... of Regulatory Affairs will be a collaborative leader with the ability to develop an effective regulatory strategy as well...
a difference at Medtronic – both in the lives of others and your career. As a Senior Principal Regulatory Affairs Specialist.... Working with global Regulatory Affairs colleagues, you will ensure submissions are accurately prepared and comply with global...
with the manager Support other Regulatory Affairs functions as needed No matter your role at BridgeBio, successful team... us at | Who You Are This experienced Regulatory Affairs team member will provide CMC regulatory expertise and support...
determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders... knowledge of regulations, standards, company SOPs and tools Assist in interactions regarding regulatory affairs...
different and innovative ways of seeing the world and solving problems. The Research Coordinator II/Regulatory Affairs... audit and quality assurance checks on regulatory documents. Lead study start-up: prepare and submit all required regulatory...