Senior Regulatory Affairs Associate Experience Biologic CMC 5+ years of experience Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to new application, post approval variations Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appr

Duties WHAT IS THE APPEALS DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Independent Office of Appeals Specialized Exam Programs & Referrals/Area 10/Team 2 The following are the duties of this position at the full working level. Conducts Appeals conferences for the settlement of the largest and most

The Attorney IV Regulatory Law will handle a variety of regulatory legal matters, including representing Duquesne Light in formal proceedings at the Federal Energy Regulatory Commission (FERC) and Pennsylvania Public Utility Commission (PA PUC), as well as providing comprehensive client counseling and strategic support on utility regulatory issues. Key Responsibilities Wo

Local submission of CTA according to the EU directive until the end of the transition period in Belgium, France, Luxembourg and Monaco, then submission according to EU CTR Local submission of MAP and NIS Education Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred Language skills Must be fluent in French and Englishcommunicat

We are looking for a Senior Regulator y Affairs Associate to join our growing team in Romania. This role can be either home or office based in Bucharest. As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trail Applications (CTA) from various European locati

include Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. Implementation of the regional strategies in support of the project globally. Lead regulatory interactions and the review processes in local region. Ensuring appropriate interaction with regional commercial teams in local re

Site Name USA Pennsylvania Upper Providence, Durham Blackwell Street Posted Date Apr 11 2024 We are looking for an ambitious Manager/Associate Director of Regulatory Affairs to ensure the development of appropriate global and/or regional regulatory life cycle strategy(s) and their execution for assigned products to meet the needs of the business. This goal has to be achie

SHIFT Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a

Support of clinical efficiency and educational experiences of the residency program with defined reporting responsibilities on residency progression and patient management to residency director/chair. The RA is responsible for accounting for all resident requested time off, oversight of patient management, financial counseling and patient payment agreements, pre authoriza

Under the general direction of the Director of Regulatory Affairs, executes the hospitalrsquo;s regulatory readiness processes to assure compliance with regulations and standards of regulatory and accreditation agencies. Assesses and determines survey readiness and compliance to all accrediting and licensing agencies by identifying areas of noncompliance and works with le