Job Openings

International Regulatory Manager

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Location
Cincinnati, OH
Salary
$70,000 - $100,000
Job Type
Direct Hire
Degree
Bachelor of Science
Date
Jun 15, 2017
Job ID
2490904
Summary Description:
This position will be tasked with leading regulatory support and expertise to business units regarding requirements for selling products and conducting business Internationally. This role leads the development, planning and execution of regulatory strategies for development, registration and post-authorization initiatives for company in International Markets with Europe being the main focus (including but not limited to: Europe, Asia, South American and
the Middle East). The incumbent advises the business units on issues of compliance, communication and claims as per country requirements, and ensures that the company’s products are in compliance with all regulatory requirements.
 
Core Competencies:
  •   Thinks & Acts Decisively
  •   Leverages Mastery
  •   Innovates & Reapplies
  •   In Touch with Performance & Needs
  •   Embraces Change
  •   Operates with Discipline
  •   Leads
  •  Builds Diverse & Collaborative Relationships
  •  Grows Capability
 
Duties and Responsibilities:
  •  Responsible for performing all European regulatory assessments for company products to meet in country requirements (and other International countries as needed).
  •  Evaluating complex regulatory requirements against the business activities and working with the functional leads.
  • Responsible for developing regulatory timelines and tracking milestones in order to ensure regulatory tasks are completed in a timely manner.
  •   Provides guidance to all appropriate departments to assure compliance with applicable regulations; remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
  •   Prepares existing and new chemical submissions as per country notification requirements.
  •   Has in-depth knowledge of cosmetic, drug, medical device and consumer DIY goods (ex: adhesives, sealants and tapes) as well as labeling expertise.
  •   Determine required warnings for each product (including First Aid Measures) as well as all required labeling elements for company.
  •  Compile and generate all necessary safety, formula, raw material and packaging information to obtain Safety Certificates for cosmetics prior to the launch of new products into the a new market (if applicable).
  •   Complete all product registrations (if required).
  •   Expertise in REACH (manage all REACH documentation, relationships and submissions).
  •   Partner and support marketing teams through concept and artwork development and guide in development of creative, claims, offering alternative solutions as appropriate and ensure all product communications are defensible. This includes understanding the different requirements by market and developing supported language for each market/country.
  •   Defend the technology and scientific data supporting communications to relevant external agencies such as governmental regulatory agencies, advertising self-regulatory groups (ie: Clearcast) and advertising clearance teams.
  •   Coordinate and oversee human, environmental, physical chemical, and other testing including assessment of new data to meet regulatory reporting obligations.
  •   Claim substantiation experience (determine appropriate and supportable claims for each NPD launch item).
  •   Execute, in partnership with R&D, all regional specific clinical and claims testing and guide brand teams on approved copy and level of risk.
  •   Collaborate and generate all necessary product and clinical trial information for product registrations, medical devices and drug products.
  •   Complete regulatory surveys (as requested)
 
Qualifications Required:
 
Education:
Seeking a highly qualified scientist with regulatory and claims experience with:
  •   A bachelor’s degree in chemical engineering, biochemistry, chemistry, biology, cosmetic science or a related biological discipline (preferred).
 
Experience and Background:
  •   3-5+ years' direct work experience in the product regulatory discipline of consumer goods, cosmetics, medical devices and/or drugs (CPG experience preferred).
  •   Strong working knowledge of the EU & International regulations and authorities governing product safety and registrations.
  •   REACH expert
  •   Knowledge of product risk management.
  •  Claim substantiation expertise and appropriateness of data to support key claims.
 
Specific Skills:
  •   Requires excellent verbal and written communication skills. Requires the ability to interact with individuals from a variety of functional backgrounds through effective communication of data & risks and influencing the outcome.
  •   Requires the ability to work on multiple projects, to organize and prioritize within and between projects.
  •   Requires flexibility, adaptability and ability to quickly assimilate and apply new information.
 
Technical Qualifications:
  •   Must be able to plan and conduct scientific, safety, clinical and toxicological testing. Must be able to draw conclusions from the results of clinical or technical studies and apply them to business decisions.
  •  Must have an understanding of the target consumer and how the target consumer interprets communication.
  •   Should have a basic understanding of the current regulatory environment and common practice in the EU market among other global markets.
 
Other Information:
Requires international travel (minimum quarterly basis to UK or as often as needed).