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.
- 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
- Conducts the copy review of labels, labeling and graphics, in accordance with
- 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,
- Understand the new product development process
- An excellent communicator, using your expertise to influence others to make
- 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 firstname.lastname@example.org.
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.