Regulatory Lead US

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Officer /Associate, RA Intelligence
  3. United States
Cambridge, USA
Posting date: 15 Feb 2021
RA.FG.35652C

Proclinical is urgently recruiting for a remote Regulatory Lead for a global medical device company specializing in material sciences developing permanent self-disinfecting products. This newly created role works closely with R&D, Product Development, Marketing, Sales, Customer Service to provide on-going, daily regulatory and technical support.

Job Responsibilities:

  • Ensures that all company products meet regulatory requirements including
    labeling, packaging, marketing collateral, etc.
  • Deliver all activities related to the implementation of regulatory strategies for
    consumer packaged goods within the business in the US and South America
  • Collaborate with different internal and external labs to get technical data
  • Responsible for registration and notification of consumer packaged goods
    according to the local (and international) regulatory frameworks
  • Prepares and submits EPA & FDA regulatory submissions, ensuring timeliness,
    accuracy and completeness of submission materials.
  • Monitors the progress of EPA & FDA regulatory filings.
  • Provision and maintenance of internal and external security documentation for
    our products (e.g. dossier, technical file, Labeling, packaging, SOPs, quality
    management file)
  • Conducts the copy review of labels, labeling and graphics, in accordance with
    regulatory requirements.
  • Remains knowledgeable of the regulatory and legal frameworks, regulatory
    requirements, and legislation applicable to the organization to ensure that
    products adhere to all relevant regulatory requirements.
  • Assist the SVP Regulatory Affairs to implement company regulatory, safety &
    environmental policies, guidelines, and procedures

Skills and Requirements:

  • Scientific background in Biology, Chemistry, Microbiology, or related fields.
  • Minimum 8 years direct or related experience in Hygiene & Home products,
  • Disinfecting products EPA or FDA registration for example, products treated with
    pesticides such as disinfectants, wet wipes, spray, hand sanitizer , anti-odor
    products , with experience of a range of different regulatory classifications is
  • Deep knowledge of antimicrobial regulations (EPA & FIFRA) and antimicrobial
    product registration requirements.
  • This position has detailed knowledge in regulatory issues and interpretation of
    regulations and legal affairs.
  • Must be skilled in analytical thinking, highly organized, well equipped for
    changing tasks, and an independent worker.
  • Maintaining high attention to detail in preparing technical dossiers, variations,
    and renewals
  • Understand the new product development process
  • An excellent communicator, using your expertise to influence others to make
    fact-based decisions
  • Results-orientated and entrepreneurial.
  • Problem solver to find solutions
  • Good interpersonal skills, teamwork, multicultural compatibility

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 or f.gbadamosi@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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