Position Title:
Job Classification:
Department Name:
Supervisor/Manager Title:
Location:
Product Safety Manager
Exempt
Regulatory, Safety and Consumer Affairs
Director – Global Regulatory, Safety and Consumer Affairs
Allendale, NJ
The xxx strategic business unit, which is a division of xxx, is a leading manufacturer and distributor of a
diverse portfolio of consumer and personal products xxx is focused on Feminine Care products, including
Gentle Glide and Sport tampons; Infant Care products, including spill-proof cups, baby bottles, pacifiers,
and Diaper Genie; Sun Care products,; and Skin Care products
Primary Purpose of this position:
With minimal supervision, manage Product Safety program for all personal care lines of business.
Supervise Product Safety Specialists. Provide in-house expertise on human health hazard evaluation and
risk assessment.
Essential Functions:
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Manage raw material and new product safety clearance program.
Evaluate the safety of all raw materials used in EPC products.
Support the new product development process by determining safety requirements for all EPC
products prior to market introduction.
Conduct safety risk assessments for all new raw materials and products following FDA/EPA risk
models to support global, federal, state and local safety requirements, including California
Proposition 65.
Provide safety testing support for all regulatory submissions including preparation of all safety
clearances and final reports.
Design and monitor all product safety pre-clinical and clinical studies.
Monitor consumer experience and submit Adverse Event Reports when required.
Administer hazardous substances management program, including MSDS authoring.
Review chemical management rules and inventories for impact to EPC products.
Experience/Education Required:
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Ph.D. in the Life Sciences. Toxicology/Biology/Pharmacology highly desired.
12+ years’ experience in an FDA-regulated industry providing product safety support and
monitoring pre-clinical and clinical testing at progressively increasing scientific levels.
Management experience.
Experience with topical products is important; experience with feminine care products is a plus.
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EPA / FDA Safety Risk Modeling experience, including risk assessment.
Microbiology background is a plus but is not required.
Skills and Abilities Required:
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Good computer skills.
Excellent verbal / written communication and interpersonal skills.
Ability to interface with internal and external contacts at all levels.
Project management, critical thinking and problem-solving skills.
Excellent communication (written/verbal), interpersonal, leadership, and coaching skills.
Good organizational, prioritizing and follow-up skills. Attention to details. Ability to handle
multiple tasks/projects simultaneously.
Ability to work well under pressure, with minimal supervision, and to interact with a variety of
contacts, including R&D staff, management, clinical laboratories, consultants, and suppliers.
Ability to organize teams and facilitate meetings.
Excellent web-based database research skills relative to toxicological and safety information.
Strong PC skills, including proficiency with Microsoft Office software, including Access/databases.
Some light lifting required, up to 25 pounds.
Position Title:
Senior Product Safety Specialist
Job Classification:
Exempt
Department Name:
Product Safety R&D
Supervisor/Manager Title:
Senior Manager / Director
New / Replacement Position:
Replacement
Location:
xxx
Primary Purpose of this position:
Plan and conduct safety/toxicological reviews, risk assessments, product safety clearances, and safety
information searches in support of product development.
Essential Functions:
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Conduct routine safety/toxicological raw material reviews for all product categories including food
contact items and provide safety support for raw materials as needed for international
registrations.
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Conduct safety/risk assessments, including Margin of Safety calculations as needed, based on
established SOPs for global safety compliance. This includes making informed judgments based
on literature searches and vendor information.
Implement the product safety clearance program under the Senior Manager / Director’s guidance.
Adjust safety testing plans as needed to meet the requirements for different international markets,
as is appropriate..
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Keep up-to-date with new technology in clinical research including biocompatibility testing
standards.
Identify and communicate any study issues that may impede the timeline of expected deliverables
to product development. Act on Senior Manager / Director’s recommendation for product reaction
follow-up to determine resolution and path forward.
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Search toxicological information to support special safety projects and industry-wide issues.
Review and approve formulae for consumer, clinical testing and commercialization. Review and
approve clinical testing reports.
Monitor clinical studies consistent with GCP and study monitoring plans as defined by corporate
policy..
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Respond to ingredient Use surveys (CIR). Consolidate information into the ingredient safety
database.
Experience/Education Required:
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M.S. degree in Toxicology, Pharmacology, or a relevant technical field.
5+ years’ experience in the OTC / Cosmetic industry providing product safety support and
conducting clinical testing at progressively increasing scientific levels per GCP (Good Clinical
Practices).
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Experience with global cosmetic and / or medical device safety requirements.
Awareness of chemical inventories and management programs is a plus.
Skills and Abilities Required:
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Solid science background, with a focus on toxicology.
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Good computer and information search skills. Electronic data management experience desired.
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Excellent database research skills relative to toxicological and safety information.
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Excellent communication skills, verbal and written, and interpersonal skills. Ability to interact with
internal and external contacts at all levels. Ability to clearly communicate information via verbal
presentations and in writing.
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Ability to establish productive partnering relationships and maintain alignment with other operating
functions.
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A strong record of problem solving and priority setting.
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Ability to act and think independently and make sound decisions.
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Ability to handle multiple tasks/projects simultaneously, as well as demonstrated ability to complete
projects on time.
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Ability to work well under pressure, with minimal supervision.
Sean Yarusewicz
Scientific Recruiter
RJS Associates, Inc.
10 Columbus Boulevard
Hartford, CT 06106
Phone (860) 278-5840
Fax (860) 522-8313
seany@rjsassociates.com
www.rjsassociates.com
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