Description
WE ARE SOFTWARE SPECIALISTS
IT Staffing Done Right the First Time
Software Specialists is an IT staffing company with extensive consulting experience in the Information Technology Industry. Incorporated in the state of Pennsylvania in 1998, we bring 15 years of experience in providing IT talent to FORTUNE 1000 Companies.
Our experience from providing thousands of IT consultants has taught us that customers require contractors with more than just the technical knowledge. Team work, cultural fit, and attitude are just as important as aptitude. Be it 1 position or 100 positions, Software Specialists' focus is on finding the "Smart Fit" for our clients' needs; this makes us not just one of the fastest growing Information Technology consulting firms in the country but also a trusted adviser to our customers in their talent acquisition process.
JOB TITLE - Regulatory SUPPORT Manager
12 Months Assignment. (PAY - $40.86/hr)
Please note, this is a Regulatory SUPPORT Manager, not a Regulatory Affairs Manager. This person will not work with registration to medical authorities.
Customer Regulatory Support is a resource within BioProcess, Life Sciences. Our main mission is to support product managers, regions and customers providing quality documents and online support in response to customer requests for quality, regulatory and technical related information.
They need to re-enforce the team with a Regulatory Support Manager, mainly working with chromatography media.
Essential Functions:
*Develop and update regulatory support documentation for products in customers regulated environment
*Perform necessary investigations, prepare and deliver statements and certificates
*Participate in creating and updating guidelines and steering documents
*Respond efficiently and promptly to customers regulatory based issues (within CSSx). This will include necessary investigations, preparations and delivery of certificates, use of available internal and external databases and other relevant databases
*File and maintain complete documentation of questions and answers in databases. Specify, prepare, update and review regulatory support documentation; RSF, VSF, CCN, statements, certificates and other regulatory related documentation for new and existing products
*Use existing web based system and expand regulatory supporting information provided on the web
*Build and maintain knowledge and understanding of customers regulatory requirements related to BioProcess business at a high level
*Act as regulatory support expert and discussion partner to R&D, QA, Product Management and other functions and regions
*Participate in project teams as regulatory support expert
*Lead cross-functional activities when required
Requirements:
*Bachelor of Science in Chemistry, Pharmacy or corresponding.
*Fluency in English, written and spoken.
*Understanding of GMP and knowledge of regulatory requirements in BioProcess business.
*Organized, target and customer oriented.
*Good communication skills
*Flexible and service minded with good collaborative skills.
*High ability to work independently.
Desired Requirements:
*Experience from industry regarding biopharmaceutical process development, stability issues and quality assurance.
*Experience from GE Healthcare product development or production.
*Expertise in the medical regulatory field
*Experience from leading crossfunctional activities
*Skills with the related systems; Lotus Notes, Magic, etc.
*Good writer and presenter