Regulatory Affairs Analyst

hace 4 días

Lima, Perú Johnson & Johnson A tiempo completo

**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
Professional
**All Job Posting Locations**:
Lima, Peru

**About MedTech**

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

**We are searching for the best talent for a Regulatory Affairs Analyst to be in Lima, Perú.**

**Purpose**
To develop a skill set enabling improved contributions while working under close supervision. This role involves planning, directing, coordinating, and controlling regulatory affairs activities related to new and modified products worldwide, ensuring compliance with corporate policies and government regulations. The position interprets new and changing regulations to uphold adherence to regulatory and government standards.

**Key Responsibilities**
- Assist in implementing compliance with regulations to ensure that developed, manufactured, or distributed products meet regulatory agency requirements.
- Conduct functional analysis and interpretation of scientific data to assess risk and create regulatory strategies, expediting new product introductions to the market.
- Contribute to cross-functional project teams in developing compliant policies and operational plans for timely commercialization of new and modified products in key markets.
- Facilitate distributor efforts to register and maintain the product portfolio in indirect market countries, ensuring adherence to all legal and technical documentation requirements.
- Provide support for Ministry of Health (MoH) notifications and ensure timely updates of internal platforms.
- Collaborate closely with the commercial team to execute global plans and assist in tenders, blockage, and eligibility processes.
- Carry out detailed regulatory submissions required for new and existing product approvals and registrations.
- Coordinate regulatory affairs interpretation and feedback in support of federal, state, and/or international regulations by preparing documentation and reports for internal and external audits.

**Key Requirements**
- Professional or advanced student in Pharmacy, Biotechnology, or a related field
- Language: Intermediate to sophisticated proficiency in English
- Experience in Regulatory Affairs (desirable)
- Technical background in Chemical Engineering
- Focus on regulatory support documentation for product registration in indirect markets, specifically aiding distributors in technical and legal documentation for compliance

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