Labeling Claims Manager - Regulatory Affairs Posted Dec 29, 2016
Pharmavite , Northridge, CA
 
We currently are seeking an experienced Regulatory Affairs Labeling Claims Manager. This key position will be based in our corporate offices in Northridge, CA (So. 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.

Our mission: People creating new products for better health worldwide.

Our vision: 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.

Position Summary:

Responsible for the proper development, substantiation and maintenance of claims, across all Pharmavite brands and platforms, domestically and internationally, in order to effectively ensure compliance with applicable laws and regulations and minimize risk as it relates to potential litigation. Responsible for managing and developing a team of direct reports.

Responsibilities:

Manages direct reports including goals setting, performance evaluation, coaching and talent development.
Ensures that new product development, claims substantiation and digital projects are achieved, per agreed upon timelines.
Coordinates and collaborates with Innovation, Marketing (Domestic & International) and Scientific Affairs in order to develop compliant, science based claims.
Works with Scientific Affairs (SA), ensures that all claims are substantiated, both upon creation and when revised, and that proper documentation relating to such substantiation is created and properly maintained
Establishes, in conjunction with SA, a regular claims substantiation review to ensure that new science is captured and considered with respect to claims and such review is properly documented.
Domestically, ensures active ingredients linked to claims are acceptable for use against relevant documentations such as but not limited to, Generally Recognized as Safe (GRAS) determinations and New Dietary Ingredient Notifications.
Supports GRAS and FDA New Dietary Ingredient (filings) filings as required.
Works with external counsel and subject matter experts on vetting claims substantiations.
Ensures the consistent use of claims across all marketing avenues (i.e. label copy, web content, marketing collateral etc.).
Reviews and approves new digital content, which includes NatureMade.com, retailer sites, social media and applications. Responsible for the maintenance of digital content by ensuring claims and other related information is up-to-date.
Creates and manages the regulatory claims files, allowing other cross functional groups easier access to approved claims.
Manages the submission of and tracks FDA 403(r)(6) 30-day notices for structure/function claims.
Manages approval of label changes, as they relate to claims.
Manages marketing material reviews and provides approval based upon established claims.
Monitors U.S. competitive claims, FTC's actions, NAD actions, litigation, news releases and other sources, as it relates to the current science of VMS products and attacks or potential attacks on VMS product claims; ensure that Pharmavite has acceptable exposure from a claim's perspective.
Provides guidance to and partners with Innovation, Marketing and Sales on product concepts, claims and formulations in order to ensure compliance with applicable legal and regulatory requirements, including without limitation in the case of domestic products FDA and FTC requirements
Monitors the development and assesses the impact of new and proposed changes in laws, rulings, regulations and enforcement activities impacting the use of ingredients, product safety, labeling and advertising.
Participates in appropriate scientific and trade associations as assigned.
Assists in identifying and addressing potential patent and trademark issues in conjunction with in-house legal counsel.
Assists Legal in researching and responding to issues related to litigation and other legal matters, as needed.
Performs other related duties as assigned.
Minimum Qualifications:

Education:

Requires a bachelor's degree in a scientific field in Chemistry, Biology, Nutrition/Food Science, Regulatory Science, or related field. Master's degree or Juris Doctorate preferred.

Certification:

Regulatory Affairs Certification (RAC) is preferred.

Experience:

Requires at least four to five years' experience in U.S. dietary supplement regulatory affairs with in-depth knowledge of FDA and FTC regulations, as it relates to claims. Managerial experience required.

Knowledge/Skills/Abilities:

Requires:

Managerial and leadership competence to coach, motivate and develop staff.
Comprehensive and working knowledge of laws and regulations pertaining to the manufacture and marketing of dietary supplements.
Competent knowledge of nutrition and health sciences.
Strong problem solving, analytical and strategic thinker with good business acumen.
Strong oral and written communication skills, including public presentation and facilitation of team meetings.
Good project management capabilities.
Ability to engage and influence cross functional team.
Working knowledge of MS Project, preferred.
Strong organizational skills with ability to multi-task well.
Self-starter as well as strong team player.
Ability to collaborate with internal and external customers to ensure good customer service
Ability to lead, develop, mentor and oversee staff.
A "big picture" perspective, taking personal responsibility for actions and maintaining a commitment to quality and integrity.
Physical Requirements:

General office environment. Duties require frequent, intense or close attention to detail.

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:

The incumbent has direct supervisory responsibility for two to three employees

Travel:

5%





Pharmavite is proud to be an equal opportunity and affirmative action employer. F/M/Disability/Vet

Visit our Product Web Sites:

http://www.naturemade.com/

http://www.soyjoy.com/

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