Senior Specialist Regulatory Affairs Posted Dec 29, 2016
Pharmavite , Northridge, CA
 
For more than 40 years, Pharmavite has been a trusted leader in the wellness industry, recognized for providing quality vitamins, minerals and supplements and all natural snacks under our Nature Made® and SOYJOY® brand names.

Who We Are: Our mission is People creating new products for better health worldwide.

What We Do: Our vision is inspiring the healthiest you through more complete nutrition... Wherever you are in life.

As a member of the Pharmavite team, employees enjoy competitive salaries and an exceptional benefits package featuring medical, dental, vision, 401K, life insurance, and long term disability coverage. In addition, employees enjoy educational assistance, credit union membership, substantial discounts on our products, and 11 paid holidays per year.

We currently are seeking a dynamic, strategic, and innovative Specialist, Sr Regulatory Affairs. This key position will be based in our corporate offices in Northridge, CA (So. CA).



Purpose of Job:

Responsible for ensuring that the domestic and/or international regulations are met, helps establish and maintain procedures and processes to ensure regulatory compliance and leads the regulatory function to provide support to enable Sales and Marketing to continue to sell current in-market products or launch new products.

Responsible for the preparation of registration applications and other regulatory submissions related to dietary supplements and/or health foods to be sold in the domestic or international markets. This position also assists in the regulatory approval of labeling artwork, advertising, product claims and packaging standards for such products.

Monitors, analyzes and assures compliance with regulatory requirements for the registration or premarket or import clearance of dietary supplements and/or health products in the domestic or international markets and is responsible for the preparation, and tracking of internal and external documentation associated with product registrations, premarket or import clearance



Essential Responsibilities and Duties:



Prepares regulatory-mandated label copy for dietary supplements and/or health foods, to meet various country-specific regulations. Proof-reads and approves label artwork based on an understanding and interpretation of product formulas, labeling, claims and other applicable regulations, contract provisions, account preferences and Pharmavite policies. Monitors formula changes and label revisions to assure compliance with domestic or foreign regulatory requirements.
Reviews formulas, bills of materials and specifications for regulatory compliance.
Develops labeling, ensuring compliance with applicable regulatory requirements.
Manages regulatory project timelines
Leads and oversees the preparation of regulatory submissions related to domestic and international products.
Works with regulatory and/or legal consultants in the U.S. or other countries to understand the regulations, ensure compliance, obtain product approvals, registrations, premarket or import clearance .
Coordinates with cross functional teams, to prepare, assess, and submit product registration and other regulatory submissions related to domestic or international products for the purpose of registering Pharmavite products or obtaining premarket or import clearance.
Coordinates the submission of applicable documents through appropriate U.S. government agencies for their legalization by applicable consulates/embassies. Updates product registration or premarket import clearance status by country.
Provides regulatory input on product development, including country-specific formulas.
Provides input on regulatory issues towards the development of domestic or international growth strategy and launch plans in the U.S. or specific countries.
Keeps abreast of regulatory changes in the U.S. or foreign countries and ensures that key personnel are kept up-to-date on such changes.
Reviews product claims intended for use in domestic or international labeling and advertising, in accordance with regulatory requirements and Pharmavite policies.
Performs other related duties as assigned.
Helps train and mentor junior staff on regulatory responsibilities and duties.
Minimum Qualifications:

Education:

Bachelor's degree in a scientific field (Chemistry, Biology, Nutrition, Food Science, or related field, etc.) is required. Master's degree is preferred

Certification:

Regulatory Affairs Certified (RAC), preferred.

Experience:

Three to five years' of domestic or international regulatory experience with a preferred emphasis in dietary supplements, health foods or pharmaceutical products.

Knowledge/Skills/Abilities:

Requires:

Ability to understand and apply information from complex materials such as product formulas, specification sheets and government regulations.
Knowledge and understanding of domestic and/or foreign country dietary supplements regulations.
Experience in compiling regulatory documents and working with outside consultants to file applications for registrations of dietary supplements, health foods or pharmaceuticals with relevant government agencies.
Ability to work, collaborate and lead meetings with multiple stakeholders in a cross functional team setting. Must be able to represent regulatory interests in an interactive team environment.
Foreign language skills, especially Chinese, Korean, Arabic or Spanish, is preferred to support international markets
Strong analytical and good oral and written communication skills.
Proficiency in word processing, spreadsheet and graphic presentation software including but not limited to Microsoft Office applications (Word, Excel and PowerPoint, Access).
Familiarity with MS Project and R.A.C.I. process is desirable.
High degree of flexibility, organization and ability to pay close attention to detail.
Ability to handle multiple projects simultaneously in a timely manner.
Physical Requirements:

General office environment. Long periods of sitting.

Environment:

Exposure to disagreeable elements is negligible.

Safety:

The incumbent must be able to perform this job safely without endangering the health or safety of self or others.



Supervisory Responsibility:

None.



Travel: 5%



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