Sr. Regulatory Specialist

Below are the Job Details
Title:- Sr. Regulatory Specialist
Location:- Pleasanton, CA
Duration:- One Year

·         The “Senior Regulatory Specialist—Dietary Supplements” position is a regulatory/ role focused on supporting the compliance and safety of products for our recently acquired Nutranext dietary supplement business.  This is a newly created position within the Global Stewardship (i.e., “Regulatory”) department of Clorox’s R&D organization and will have an emphasis on FDA compliance of the U.S. Retail, Private Label and Direct to Consumer businesses.   Future responsibilities could grow to include international regulatory coverage. 
The successful candidate will lead in developing regulatory strategies to support existing products and new product launches. He/she will provide leadership for innovation and commercialization projects to resolve regulatory issues with a balance of driving compliance while meeting business needs.   Cross-functional collaboration with colleagues both within and outside of R&D (e.g., Product Development, other Global Stewardship members, Legal, Corporate Quality, Marketing, Government Affairs, etc.) is required on a daily basis.  
 
Key Responsibilities (in descending order of importance) and % of Time:
o    Provide Regulatory leadership and recommendations to innovation and commercialization project teams.
o    Review dietary supplement ingredients/formulations, claims and labels for compliance to support innovation and projects for the NXT, Private label (PL) and Direct to consumer (DTC) dietary supplement businesses. (50%)
o    Enable GS review of NXT, PL and DTC product safety, through appropriate GS members and provide recommendations to project teams. (20%)
o    Monitor and proactively communicate emerging/changing dietary supplement regulations, interpret related information and summarize impact for other functions/leadership teams. (10%)
o    Lead and/or support cross functional teams, as required, to drive continuous improvement in Regulatory processes. (10%)
o    Proactively partner with GS team members in other dietary supplement businesses (e.g. Renew Life) to drive efficiencies. (10%)


MINIMUM REQUIREMENTS:
o    Years and Type of Experiences
o    At least 6-8 years experiences (preferably in industry) in the FDA dietary supplement Regulatory space.
o    In-depth working knowledge of FDA dietary supplement product regulations, guidance and policies for label claims, ingredients, formulations and processes.
o    A thorough understanding of the FDA enforcement landscape (e.g. including trends/hotspots and state versus federal enforcement).
o    Demonstrated ability to successfully support product launches utilizing dietary supplement Regulatory knowledge.
o    Critical evaluation and interpretation of proposed legislation and existing regulations to determine and clearly communicate business impact to stakeholders.
 
Highly desirable:
o    Experience in regulation of dietary supplements (equivalent) outside of the U.S.  (e.g., Canada Natural Health Products, European Food Supplements, etc.).
o    Manufacturing QA/QC experience.
 
o    Soft Skills and Abilities:
o    Strong leadership skills to lead projects, to stand up to “do the right thing”, to drive change and influence cross-functional partners.
o    Demonstrated ability to prioritize and drive work with a high degree of independence.
o    Ability to balance Regulatory compliance against business needs and provide choices to teams.
o    Ability to work on cross-functional teams and form solid business relationships across functions.
o    Strong interpersonal, verbal and written communication skills.
o    Strong analytical and problem-solving skills.
o    Ability to travel 10-20%, as required.
 
o    Education Level/Degree:
o    Minimum Bachelor of Science degree (or equivalent) in a relevant technical field. Advanced degree preferred. Prior work experience will be considered more important
 

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