CTG Regulatory Affairs Specialist in Durham, North Carolina
Title: Regulatory Affairs Specialist
Job Number: 17203721
CTG's premier global client in RTP, NC, has a long term assignment for a Regulatory Affairs Specialist! The candidate will be assigned as the Product Chemistry and Compliance Specialist (PCCM) and will assist the PCCM in the USA to execute standardized functions that will enable the PCCM to focus on managing the compliance, workflows, Technical Grade Active Ingredient (TGAI) and industry processes. The successful candidate will also enable the Registration Manager in Environmental Science (ES) regulatory to focus more on the management of their products with the EPA, by taking on administrative tasks on the client’s internal computer aided processes to support global product compliance (CHAMP, RegPrime). Additionally, the candidate would be able to fill in for the PCCM, in the PCCM’s absence, as there is currently no backup, potentially providing succession planning for the PCCM position.
Major responsibilities of this position are:
Receive the product composition change request from the global organization and coordinate the change process from planning to submission with registration manager and product chemistry manager and update the supporting systems (CHAMP, RegPrime, DART, BRIDG) accordingly for the Environmental Science business US
Generate the Confidential Statement of Formula (CSF) and supporting Product Chemistry documentation for submission to the EPA for composition changes or new products for the Environmental Science business US
Convert CSF documents into deconstructed data, to realize the full benefit of the data in the BRIDG system
Serve as a reviewer for CSFs that are generated to ensure compliance with our production documents
Perform periodic audits of current specifications vs what we understand to be current, and specifications vs the current CSF
Foster and support change management to implement the new and enhanced systems
Serve as the backup PCCM for USA
Apply technical basis knowhow to product chemistry related projects
Manage and lead multiple tasks in a very complex environment
Communicate well and clearly with different levels of management hierarchy and with different business partners with diverse backgrounds
Liaise with required business partners and work independently
PhD with minimum of 3 years relevant experience or MS with minimum of 5 years relevant experience or BS with minimum of 7 years relevant experience
Chemistry background (preferred in the pesticide or equivalent business)
Profound computer skills (experiences working with database)
Experiences in a regulated environment (working with EPA under FIFRA preferred)
This position pays on a W2 hourly basis (no C2C or 1099's).
APPLY NOW for resume review by recruiter Pam Gewin!
IMPORTANT NOTE: All qualified candidates must successfully pass a background check and a drug screen to be considered for the position.
CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
CTG is the most reliable IT services provider, built on 50 years of meeting our commitments to make technology work for clients and deliver real business value. CTG provides industry-specific IT strategy, services, and solutions that address the business needs and staffing challenges of clients in high-growth industries, including major technology companies, large corporations, and government entities located in North America and Western Europe.
CTG's greatest asset is its people, and as such we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work Company by Modern Healthcare (since 2013) in North America, and a Best Places to Work Company in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
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