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Regulatory Lead US
- Permanent
- Senior/Director & VP, Officer /Associate, RA Intelligence
- United States
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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