(Senior) Regulatory Affairs Consultant /

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Coordinates the preparation of CMC regulatory submissions that meet global regulatory requirements, represent CMC regulatory at team meetings. Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs) and agency communications (responses to questions) are prepa...

Senior Regulatory Affairs Associate. ...

Coordinates the preparation of CMC regulatory submissions that meet global regulatory requirements, represent CMC regulatory at team meetings. Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs) and agency communications (responses to questions) are prepa...

Previous CRO / Pharma experience working in the capacity of a Regulatory Affairs Consultant or Senior Regulatory Affairs Consultant with CTA submission knowledge is essential, knowledge in MAP and NIS would be a plus. We are recruiting for a French Speaking Senior Regulatory Affairs Associate in Eur...

For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Environmental Regulatory Specialist. Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...

Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risk...

Minimum of 7 years of Regulatory Affairs experience; preferably using data, software, and services to enable processes, make decisions, and deliver value. Hands-on/practitioner experience (or extensive client-facing consulting experience) within the Regulatory landscape, Intelligence, and Regulatory...

Successful track record of providing robust regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance Experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs) Ability to effectively liaise with ...

The Senior Manager, CMC Facilities Regulatory Affairs will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment aspects. Management of facilities and equipment matters required for INDs, registration a...