Regulatory Affairs Associate

2 days ago

Remote, India Endeavor Consulting Group Full time

Leading Global Cosmetics Consumer Products, Personal Care / Pharmaceutical corporation has an immediate need for an experienced Regulatory Affairs Associate. This is an excellent opportunity to join one of the world’s most respected and trusted companies.

**Responsibilities**:

- Review and respond to project team cross functional partners to provide expertise, recommendations and guidance.
- Review ingredient lists against formula to ensure INCI names
- Provide final approval of ingredient list along with support of marketed products lead before distributing to the project team
- Review artwork to ensure labels are compliant with the regulatory requirements according to product classification (e.g. cosmetic or OTC drug)
- Review / approve Raw Material information for compliance with local, state, federal and internal regulations and SOPs
- Review / approve formulations for compliance with local, state, federal and internal regulations and SOPs
- Understand desired outcome and approve study release documentation
- Generate / provide INCI lists
- Review / approve associated manuscripts, production graphics, websites, TV, and other communications for accuracy and Regulatory compliance
- Prepare, review and approve APR / GCC as appropriate
- Prepare documentation for Product Registration

**Requirements**:

- Prefer 3+ years of appropriate RA experience with BSc or equivalent
- Understanding of Regulatory product classifications and ability to determine appropriate claims support for product category
- Understands and has in depth working knowledge of the regulatory landscape (local, state, federal)
- Self directs against set timelines, and can take appropriate action to minimize delays and can anticipate difficulties. Primary point of contact with project team
- Works with a high degree of independent judgment and execution
- High level of organizational understanding and awareness in decision making

**Preferred Experience**:

- Drug Facts panel review
- Knowledge of CFR for cosmetics
- Experience in FDA Submissions/Filings
- OTC / Monograph experience
- Cosmetics experience
- Raw Material Document review (Certificate of Analysis) Cross functional Team experience

**Benefits**

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We are committed to providing accommodation for employees with disabilities.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management._

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