Regulatory Lead US

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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