Regulatory Affairs Specialist III
is responsible for the development and implementation of regulatory compliance programs for EMD Millipore Corp
Provides advice and counsel with respect to product labeling and literature relative to compliance with applicable regulations
- Employ significant working knowledge of FIFRA Regulations and EPA pesticide product registration processes to achieve assigned goals.
- Responsible for compliance with all relevant regulations relating to antimicrobial products (biocides) in North America
- Responsible for the submission of FIFRA 6(A)(2) adverse reaction reports
- Communicate progress of registration projects to management to support plans for product launch.
- Assure that all required reports to authorities are submitted on time.
- Assure that state pesticide registrations are maintained in current status and compliant with regulations.
- Support Hazard Communications procedures for labels and MSDSs for biocides and other associated chemical as well as input of data into SAP
- Regularly monitor reliable sources of information for changes in relevant regulations and update management in a timely manner.
- Represent company in discussions and negotiations with authorities and relevant bodies on activities as assigned.
- Provide Customer Service support (regulatory) for products
- Employ extensive knowledge of chemical inventory registration requirements (TSCA, DSL, REACH and similar requirements globally) to contribute to the registration process of products globally
- Responsible for the submission of TSCA 8(c) and 8(e) adverse reaction reports as well as Inventory Updates
Collaborates with outside counsel in representing the company’s interests
May audit raw material vendors and prepare manufacturing documentation for updated filing.
Represents company in dealing with federal agencies and trade associations
Coordinates inter-department activities
Create regulatory statements as required by customers such as BSE/Origin, residual solvents, GMO, Kosher, Halal, Melamine, & others as required
May be required to perform additional tasks as needed
A general working knowledge in the following regulatory areas would be beneficial: FDA Food, Drug, Medical Devices and Cosmetics.
BS in Chemistry, Biology or related health science
Minimum of 7 to 10 years of Regulatory Affairs experience
MS in Chemistry
Multilingual & SAP computer software knowledge & experience
EPA Electronic Registration Experience
EMD Serono - 2 years ago
EMD is the North America name of Merck KGaA, Darmstadt Germany. We are a global pharma, chemical and life science company. In the United...