Bayer posted a job you might be interested in January 30, 2015 at 09:24PM

Bayer



Regulatory Compliance Specialist

Raleigh-Durham, North Carolina Area, US - Biotechnology

Major Tasks:

• Establish TSCA Coordinators at each site and lead a BCS TSCA Committee comprised of those Coordinators, maintain a list of active current members and document any issues or actions. Develop and maintain TSCA and FIFRA procedures, policies and training and ensure timely reviews/updates;

• Evaluate chemical compositions of new and existing BCS products and raw materials and determine regulatory status under TSCA for immediate sale or need for registration via the Pre-Manufacture Notification process. Represent department on mergers and acquisitions teams to ensure compliance;

• Support 8C/8D/8E reporting requirements by maintaining records of allegations, identifying reportable studies at BCS facilities, and inventorying studies/exposures/patterns of substantial risk. Ensure that required records are maintained and reporting to EPA is made when required;

• Represent BCS to EPA, Customs and Border Protection and other regulatory agencies during inspections, audits, preparation/processing of Pre-Manufacturing Notification applications, Notices of Commencement, etc. Evaluate the applicability of import and export regulations and monitor processes to ensure compliance with all applicable TSCA and FIFRA regulations;

• Support EPA inspections by reviewing inspection documentation/findings, delivering required notifications/communications (internal and external), and maintaining required related records. Ensure that all action items are documented, assigned and tracked to completion;

• Provide support and oversight for EPA registered production facility section 7 establishment inspections;

• Ensure execution of compliant export procedures as detailed in 40 CFR 168. Ensure compliance with books and records obligations as detailed in 40 CFR 169 for the company and the individual locations;

• Ensure compliance of labels and other materials necessary to conduct import / export programs including, but not limited to: Labels and their contents as they practically apply in product supply; Purchaser Acknowledgement statements; Annual production reports under Sec. 7 of FIFRA; EPA Notices of Arrival; BCS e-label server; PR 99-1 procedures; Develop R&D labels for import of samples;

• Participate in industry associations and initiatives pertaining to EPA and other applicable regulatory agency actions related to TSCA and FIFRA import/export.











No salary provided



Posted January 30, 2015 at 09:24PM from LinkedIn http://ift.tt/1wJB5xG

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