Regulatory Affairs Analyst

Job Title: Analyst, Regulatory Affairs
Location: Remote
Duration: 6 months

Regulatory Affairs play a pivotal role in bringing and maintaining our products in the market. Ensuring compliance with local regulations, understanding government policies, and fostering relationships with key stakeholders are integral to Client's success. The Analyst will focus on delivering compliant products while navigating the changing regulatory landscape in the US.

The Analyst, Regulatory Affairs is responsible for supporting the launch of marketed products, including developing mandatory product label text, regulated claims, and nutritional information in the form of Label Information Notes (LINs) as well as tracking post-market regulatory surveillance. The candidate will be involved in horizon scanning for the US market in preparation for future regulatory requirements. This position will be pivotal in providing guidance to various project teams and competitive advantages and ensuring compliance for client products.

Job Responsibilities:

• Analyze product formulations to provide mandated labelling content by working closely with R&D scientists while delivering against desired marketing requirements in a compliant manner.
• Review and approve final product labels, ensuring compliance with local legislation and market authorizations.
• Ensure product formulations and ingredients comply with FDA regulations.
• Provide regulatory input for early innovation of new products by reviewing marketing concepts and claims for consumer studies.
• Ensure appropriate scientific support of US-based products claims to obtain the most competitive labelling possible.
• Monitor the regulatory and governmental environment and identify impact to products. Support label changes resulting from new or updated regulations.
• Manage regulatory projects to deliver against regulatory initiatives.
• Provide regular updates to matrixial teams on projects to ensure alignment in areas of responsibility.
• Manage all paper, electronic files, and information management databases.
• Enhance the effectiveness and efficiency of the Regulatory Affairs Department by supporting and improving various systems and processes.
• Build strong relationships within division/departments on both local and global levels and with external stakeholders.

Qualifications :

• University degree in a scientific field (B.S., Food Science, Biology, Chemistry, Toxicology, or Nutrition) required; M.S. preferred.
• Minimum of 3 years of experience in Regulatory Affairs at a Consumer Products Company.
• Proficient in computer applications (MS Word, Excel, PowerPoint, Adobe Acrobat, Access, Optiva).

Competencies

• Self-motivation, tact, and high attention to detail.
• Ability to build collaborative relationships both internally and externally.
• Multi-task project management and priority setting skills.
• Strong communication, influence, and negotiation skills.
• Ability to work in a constantly changing, fast-paced work environment.
• Ability to work as part of a multidisciplinary team and collaborate across departments.
• Ability to travel occasionally as required.

About TekNinjas

TekNinjas is a global IT staffing partner placing skilled professionals with leading enterprises and system integrators across the US, Canada, UK, India, and the EU. We focus on the right fit - not just the fast fill - and stay engaged with our consultants well beyond the start date.

We're the right partners in your success.

TekNinjas is an Equal Opportunity Employer.