West Hills, California Head of Regulatory Affairs

KEY RESPONSIBILTIES: 

• Develop strategic direction for Pharmavite’ s regulatory affairs team to include creating functional strategies and specific objectives to support functional infrastructure and the organization as a whole. Develop and deliver near-term business plans that create competitive advantage, are aligned with internal key stakeholders and with the company’s business goals and meet or exceed Pharmavite’ s business objectives. 

• Provide strategic counsel to specialty brands. 

• Provide FDA regulatory support and guidance to project teams.  

• Prepare FDA regulatory submissions, including but not limited to, structure/function notifications, GRAS, NDIN, technical files. 

• Provide strategic direction and guidance for dietary supplements.  Proactive willingness to engage, learn, and work with outside experts in other categories is a must (devices cosmetics, OTC, medical foods). 

• Apply, existing and new FDA regulatory requirements as they relate to company products, procedures, scientific research, and record keeping.  

• Provide advice regarding potential or existing claims for products (all types), including providing input on possible interpretations and implications of claims, label design and label architecture. 

• Keeping apprised and assess the impact of new and proposed changes in laws, rulings, regulations and enforcement activities that may impact the use of ingredients, product safety, labeling or claims advertising. In partnership with Legal Affairs, submits comments on proposed changes to same to FDA and FTC.  

• Primary ‘owner’ of products labels; review and advise on labeling (including supplement facts box, appropriate cautions/warnings and directions for use), and training materials.  

• Provide regulatory insights and guidance related to new product concepts, claims and formulations.  

• Recruit, retain and develop regulatory staff to meet organizational needs.  

• Act as a direct liaison with FDA regarding required submissions to FDA (outside of those done by Quality) 

• Respond to requests from FDA relating to submission made to FDA.  

• Support the Company’s recall efforts and Quality’s response to FDA facility inspections. 

• Support Consumer Affairs responses to consumer inquiries regarding products 

• Maintain corporate confidentiality at all times. 

• Develop and maintain relationships with key Pharmavite team members across several departments, including Legal, Marketing, Sales and Innovation, R&D.  

• Communicate and provide training, as needed, on new and revised laws and regulations relating to use of ingredients, product safety, labeling or claims advertising to ensure full understanding and compliance within the organization.  

• Actively participate in Regulatory Committees and other trade association groups, be the regulatory voice of the company with respect to ingredients, products and claims.  

• Assists Legal Affairs in researching and responding to issues related to litigation, agency and NAD/TINA proceedings and other legal matters.  

• Closely partner with Legal Affair on pertain matters. 

• Performs other related duties as assigned. 

WORK WITH PURPOSE: 

At Pharmavite, every employee has a stake in bringing the gift of health to life. We never shy away from disruptive innovation and tough challenges because we are making real nutrition accessible to consumers everywhere in new and separate ways. And because we know every nutrient, we make matters, we must make sure each one is exactly right before we make it ready for use. With this great responsibility comes the satisfaction that your contribution makes a real and significant difference. 

IDEAL CANDIDATE PROFILE: 

• At least 8 years of experience including broad regulatory management and strategic development experience, with an emphasis on regulatory issues related to dietary supplements.  

• Requires a four-year college or university degree or its equivalent, preferably in the physical or life sciences. Master’s degree a plus.

• Experience in other categories such as OTC, cosmetics, medical foods is a plus. 

• The ideal candidate for this role will have a comprehensive knowledge of laws and regulations in an FDA regulated environment 

• The ideal candidate will have experience in the preparation and submission of dossiers and documents to the FDA; a pre-existing relationship/interaction with FDA is preferred. 

• Can work hybrid - must be in office on Tuesday and Wednesday with some Thursday's as needed.

• Sponsorship is not available.

CRITICAL SUCCESS FACTORS: 

• Demonstrated ability to develop talent  

• The ability to think strategically and execute tactically across a matrixed organization 

• The ability to influence both externally with the FDA and internally with the team and cross functional partners at all levels in the business 

• A "big picture" perspective, taking personal responsibility for actions and maintaining a commitment to quality and integrity. 

• Ability to work alone or as part of a team and willingness to “role up sleeves” and do the work.