International Regulatory Affairs Manager Posted Dec 29, 2016
Pharmavite , Northridge, CA
 
We currently are seeking an experienced, and strategic International Regulatory Affairs 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.

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

What We Do: 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 corporate-wide compliance with all applicable laws and regulations affecting the labeling, advertising and composition of products made for foreign markets. Responsible for managing and developing a team of direct reports.

Responsibilities:

Manages direct reports including goals setting, performance evaluation, coaching and talent development.
Manages direct reports to ensure that foreign product registrations are achieved on timely basis.
Assures that existing and new products comply with all applicable foreign laws, rulings and regulations affecting the use of ingredients, labeling, advertising and claims of product.
Provides guidance to and partners with Marketing and Sales on product concepts, claims and formulations to assure compliance with applicable regulatory requirements enforced by relevant government agencies in foreign markets.
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, claims and advertising. Draft comments and vet with head of department and consult with business partners on proposed changes before submitting to regulatory agencies as deemed appropriate. Communicates new requirements and changes within the organization to ensure compliance.
Participates in appropriate international scientific and trade associations as instructed by head of department.
Assists as needed Legal Affairs to identify and address potential patent and trademark issues in foreign markets.
Assists Legal Affairs in researching and responding to issues related to litigation and other legal matters, as needed.
Performs other related duties as assigned by head of department.


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 preferred.

Certification:

Regulatory Affairs Certification (RAC) is preferred.

Experience:

Requires at least five years experience with exposure and/or hands-on experience in regulatory affairs and product compliance related to dietary supplements and health foods in international markets. Managerial, leadership and project management experience are essential.

Knowledge/Skills/Abilities:

Requires:

Managerial and leadership competence to coach, motivate and develop staff.
Working knowledge of laws and regulations pertaining to the manufacture, registration and marketing of dietary supplements and/or health food products in international markets.
Advance knowledge of nutrition, food science, chemistry and math. .
Strong problem solving skills, strategic thinking with good business acumen
Strong oral and written communication skills, including public presentation and facilitation of team meetings.
Working knowledge of MS Project and RACI process and ability to engage and influence cross functional team for project alignment.
Strong organizational skills with ability to multi-task well
Self-starter as well as strong team player
Ability to collaborate with internal and external stakeholders to ensure good working partnership.
A "big picture" perspective, taking personal responsibility for actions and maintaining a commitment to integrity, quality and excellence.
Foreign language skills preferred.
Physical Requirements:

General office environment. Long periods of sitting and use of computer.

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 one to seven employees.

Travel:

10-30% per approval by head of department.





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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