Regulatory Lead US job in Durham, USA

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Senior/Director & VP, Officer /Associate, RA Intelligence

Location: United States

This vacancy has now expired. Please see similar roles below...

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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