Associate Regulatory Affairs

Purpose: Description - Ensure all CMC documentation and regulatory submissions are prepared to meet global regulatory standards and provide information for US and worldwide submissions.
- Produce approvable CMC components of regulatory dossiers with appropriate manufacturing flexibility.
- Provide regulatory input on project teams.
- Work with QA, QC and Manufacturing to assure that all regulatory requirements are met.
- Advise on the creation and revision of SOPs governing CMC activities.
- Review and approve all changes to manufacturing processes to ensure compliance with global regulatory guidelines.
- Advise project teams, Operations, Quality, and R&D on appropriate specifications for raw materials, manufacturing components, process intermediates, and finished products to assure adequate regulatory controls for the life cycle of all regulated products.
- Performs other related duties as assigned.

Requirements

- 0-3 years experience in Regulatory Affairs.
- BS degree (advanced degree preferred) in a related technical or scientific discipline
- Ability to communicate effectively orally and in writing.
- Ability to function independently.
- Highly organized.
- Capable of supporting numerous projects simultaneously.
- Strong interpersonal and communications skills, collaboration/teamwork, and adaptive skills required.
- Knowledge of US and ICH requirements for investigational drug development and post-approval compliance.
- Ability to travel as neededClassification:Direct PlacementCompensation:
BOE YearJoin Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
IND, NDA, FDA, ICH, REGULATORY AFFAIRS, SOPContact Information
Contact:Griffin,Matthew E