Regulatory Affairs Specialist
1753 EMD Chemicals Inc. - 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

·

Merck Serono S.A - 14 months ago - save job - block
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