Sr. FDA Regulatory Affairs Specialist, OTC Drugs & Medical Devic

Company Name:
Job Description:
The Sr. Regulatory Affairs Specialist is a technical role focused on Drugs and Medical Devices. The RA Specialist will be part of a team responsible for ensuring the safety, efficacy and compliance of new products and existing products, with a current emphasis on skin antisepsis.
The position requires technical knowledge and the ability to support a robust pharmaceutical and device program for well established brands and new product launches, preparing the key stakeholders in navigating through emerging regulatory hurdles, and enabling innovative consumer meaningful claims.
In addition to effective communication with all levels in the organization, the position requires establishing guidelines, processes and practices to support and assure robust compliance on an on-going basis.
Regulatory Affairs Journey:
The Clorox Company is committed to helping save lives by stopping the spread of infection. Clorox's EPA registered disinfectants are some of the most powerful tools hospitals use to sanitize hard surface to combat germs that can cause infections. The next step in this exciting journey is to combat the germs found on skin that can cause infection. Reaching this goal requires a passionate regulatory professional who shares the same drive and goals
Minimum of Bachelor of Science Degree in biology, chemistry or related field or regulatory affairs.
5-10 years of regulatory experience in drug regulated area.
Experience in NDA and/or aNDA submissions, 510(k) and/or PMA submissions
Experience in regulatory compliance of OTC drugs
Experience in quality assurance of drugs and devices preferred
Possess strong interpersonal skills, strategic thinking, and executional ability.
Strong capability to prioritize with multi-tasking demands.
Excellent in team environment as well as working independently.
Excellent oral and written communication skills.
If you are unable to fill out the online application due to a disability, please call our main number, or email , and ask for an HR representative to assist you.
The Clorox Company and its subsidiaries is an EEO/AA/Protected Veteran/Disabled/LGBT employer.

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