Senior Associate of Regulatory Affairs

Purpose: Duties: - 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.
- Serve as CMC advisor on regulatory issues relating to both developmental and marketed products to allow timely completion of development plans.
- 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:
- 3-5 years experience in Regulatory Affairs with significant CMC experience.
- 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.
- Significant experience in relating FDA regulatory requirements to CMC planning and product evaluation leading to FDA approvals
- Ability to travel as needed

At Aerotek Scientific we help CRO's, Biotech and Pharmaceutical companies grow their business by rapidly providing reliable employees that fit perfectly into their corporate culture. Our existing clients mainly partner with Aerotek Scientific to quickly augment staffing levels for customer projects and recruit for special needs across professional and technical disciplines. Our daily recruitment efforts are focused in the areas of clinical research, drug safety, regulatory affairs, data management, programming, administrative and executive level management.

Aerotek CRA Referral Program ? Make money for helping Aerotek recruit qualified CRA.

If this position is not right for you, and you know someone that would be, you can work with us in putting consultants to work! If the individual works on this study you will receive $750!!! CALL IF YOU ARE INTERESTED, I LOOK FORWARD TO HEARING FROM YOU!!

Classification:
Direct Hire

Compensation:
DOE Year

Join 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:
Rerulatory Affairs, OTC, SOP, FDA, Pharmaceutical, post marketing, CMC, QA, QCContact Information
Contact:Anthony,Jaclyn