Regulatory Affairs Manager

**Company Description**

ArtiXio is a global consulting and services company specializing in Regulatory Affairs, Market Access, and Pharmacovigilance for pharmaceutical, biotech, cosmetics, medical device, and dietary supplements manufacturers. Our services cover compliance, regulatory intelligence in over 70 countries, regulatory operations, post-market surveillance, commercial services, and communication strategies.

**Role Description**
- Client Full Representation before Chilean Health Authority (ISP), including responsibilities in GICONA's system.
- Client QA responsible in Chile.
- Product Release, (CoA, GICONA, etc.) with electronic signature.
- Interaction with Local Legal Representative (Client CL in Chile)
- Interaction with Client's LATAM RA team (BR) and Client global QA (UK).
- QC Waivers request for each imported batch.
- Interaction and coordination with third parties from Client CL for product release.
- Complaint Management (QA Local Function) initial reception and information transfer to Global Client QA.
- Be informed of PV activities.
- Spontaneous Adverse event reception (only if applicable) Regulatory Documentation and Compliance
- Experiences working on classification and registration of Orphan drugs, small molecules
- Perform Reg assessment
- Provide Reg Intelligence

**Lifecycle Management**:

- Handle post-marketing changes, including manufacturing updates, labeling revisions, and formulation improvements.
- Monitor regulatory guidelines and implement necessary changes in product documentation.
- Ensure timely renewals of product licenses and registrations.

Labeling and Packaging Compliance:

- Review and update product labels, leaflets, and packaging as per regulatory requirements.
- Collaborate with cross-functional teams to ensure compliance with labeling changes.

Stakeholder Collaboration:

- Coordinate with R&D, Quality Assurance, and Manufacturing teams for regulatory submissions.
- Communicate effectively with regulatory agencies to address queries and resolve issues.
- Act as a liaison between the company and regulatory authorities for maintenance activities.

Audits and Inspections:

- Support regulatory inspections and audits by providing necessary documentation.
- Implement corrective actions and ensure compliance with inspection findings.

Monitoring and Reporting:

- Stay updated on changes in global regulatory requirements and guidelines.
- Assess the impact of regulatory changes on existing products and advise on mitigation plans.
- Prepare and circulate reports on regulatory activities and compliance status.
**Qualifications and Experience**:

- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Experience: 10-12 years of experience in regulatory affairs, with a focus on Orphan drugs and small molecules

**- Knowledge**:

- Strong understanding of regulatory frameworks (e.g., ICH, WHO, FDA, EMA, and other regional agencies).
- Knowledge of pharmacovigilance requirements is a plus.
- Skills:

- Excellent organizational and project management skills.
- Strong communication and interpersonal abilities.
- Detail-oriented with a proactive approach to problem-solving.
**Additional Requirements**:

- Ability to work in a cross-functional and fast-paced environment.
- Flexibility to adapt to changing regulatory landscapes and priorities.
- Commitment to maintaining high ethical and compliance standards.
**Benefits**:

- Competitive salary package.
- Opportunities for professional growth and development.
- Collaborative and innovative work environment.

**Job Types**: Full-time, Contract
Contract length: 12 months

Pay: $3,154,656 - $3,943,320 per month

Application Deadline: 19/12/2024
Expected Start Date: 01/01/2025