Regulatory Affairs Specialist
EMD Serono - Philadelphia, PA

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The

Regulatory Affairs Specialist III

is responsible for the development and implementation of regulatory compliance programs for EMD Millipore Corp

Philadelphia

site.

Responsibilities:
  • 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
Provides advice and counsel with respect to product labeling and literature relative to compliance with applicable regulations

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.

Qualifications

EXPERIENCE REQUIRED:
BS in Chemistry, Biology or related health science

Minimum of 7 to 10 years of Regulatory Affairs experience

EXPERIENCE PREFERRED

:

MS in Chemistry

Multilingual & SAP computer software knowledge & experience

EPA Electronic Registration Experience

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EMD Serono - 2 years ago - save job
About this company
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EMD is the North America name of Merck KGaA, Darmstadt Germany. We are a global pharma, chemical and life science company. In the United...