Regulatory Affairs Associate

Position Summary:

With emphasis on cosmetic products and over-the-counter drugs for the region of North America (US/CAN), provides regulatory guidance and advice on regulatory requirements. Monitors regulations and State and Federal Levels. Assesses and communicates impact to different lines of business. Develops compliance strategies to introduce new products to market. Manages notifications and submissions to governmental bodies in the US and Canada. Authors internal regulatory guidelines, protocols, work instructions and standard operating procedures. Assures all internal reporting systems and documentation comply with applicable regulatory standards and requirements for OTC drug, cosmetic products. Hands-on responsibilities for the support of product listings, manufacturing facility registrations for the US and Canada markets.

All employees at VB Cosmetics aim to build a healthy company whose members share a common goal, accept personal responsibility, earn each other’s respect, excel in their tasks, help each other be successful, participate in the profits and provide creative, enjoyable opportunities for all.

Responsibilities and Essential Duties

• Design and implement Regulatory Affairs strategies, policies and objectives in accordance with Company strategic plans.

• Monitor and interpret changes in laws, standards and regulations; determine impact to business.

Provide regulatory guidance, risk assessment and management throughout the product lifecycle: New Product Development and Commercial Innovation projects.

• Prepare submissions and reports for government agencies as required by product regulatory classification.

• Develop impact assessments and drive implementation of compliance plans.

Review of product labels to ensure compliance with country-region specific labeling requirements.

• Manage pre-market product listings and manufacturing facility registrations where needed to enable product sale.

• Maintain product registration/license portfolio for US and Canada, up to date.

Co-leads inspection visits by government officials or on internal audits

• Author or approve Regulatory and cross-functional guidelines, protocols, work instructions, SOPs.

Support and drive process improvements.

• Participate as an effective member of cross-functional product teams.

• Build library and network of regulatory resources.

• Maintain specialized product category knowledge.

Skills Required

• Required Education, Skills and Experience

• B. A. / B.S . in chemistry, engineering, or life sciences

• 5 years of related experience with a B.A. / B.S. degree, within over-the-counter drugs and cosmetics

• Knowledge and experience on FDA and Health Canada regulatory and applicable laws and regulations, as well as of cGMP standards.

• Some light lifting required, up to 25 pounds.

• The position may also require occasional travel to other company locations and to external meetings.

Desired Skills and Experience

• Strong knowledge and experience with OTC, cosmetic products regulatory frameworks, with emphasis in the region of North America (US/CAN).

• Strong technical skills.

• Solid critical thinking and influencing skills.

• Good negotiation skills, diplomacy, tact and professional judgement are required.

• Effective verbal / written communication, interpersonal, and relationship building skills.

• Ability to interface with internal and external contacts at all levels. Ability to clearly communicate technical and non-technical information via verbal presentations and in writing.

• Ability to handle multiple tasks / projects simultaneously.

• An independent thinker with ability to make sound decisions.

• Solid computer skills. Proficiency with Word, Excel, PowerPoint, e-mail and internet applications.

• Experience with ERP/QMS software