Regulatory Affairs Executive

5 days ago


Dubai, United Arab Emirates MAXZAIN HEALTHCARE Full time

**Job Summary**:
**Key Responsibilities**:

- **Regulatory Strategy and Compliance**:

- Develop and implement regulatory strategies for new product registrations, renewals, and variations.
- Ensure all company products comply with applicable regulations, standards, and guidelines, including FDA, EMA, MHRA, TGA, and other relevant regulatory bodies.
- Maintain current knowledge of regulations, guidelines, and standards applicable to company products and proactively communicate relevant updates.
- **Regulatory Submissions and Documentation**:

- Oversee and manage submission timelines, ensuring timely responses to regulatory agency questions and requirements.
- Conduct detailed reviews of labeling, promotional materials, and other documents to ensure regulatory compliance.
- **Liaison and Communication**:

- Act as a key contact with regulatory authorities, handling inquiries and maintaining positive relationships to facilitate approvals.
- Collaborate closely with cross-functional teams, including R&D, quality, clinical, and marketing teams, to ensure alignment on regulatory objectives and strategies.
- Support and guide internal teams on regulatory issues and compliance requirements.
- **Risk Assessment and Change Management**:

- Identify regulatory risks associated with product development and commercialization and provide recommendations to mitigate these risks.
- Manage changes to products, labeling, and other critical areas to ensure continuous compliance with regulations throughout the product lifecycle.
- **Post-Market Surveillance and Reporting**:

- Oversee post-market activities, including adverse event reporting, field safety notices, and recalls, if necessary.
- Ensure compliance with pharmacovigilance or post-market surveillance requirements.
- **Documentation and Record Keeping**:

- Maintain accurate records of regulatory submissions, correspondence, and related documents.
- Prepare and maintain regulatory reports, summaries, and presentations as needed.

**Qualifications and Skills**:

- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
- Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
- Strong knowledge of regulatory guidelines and processes for major regulatory bodies (e.g., MOH-UAE, DOH, DHA, FDA, EMA, MHRA).
- Excellent organizational skills, with the ability to manage multiple projects and deadlines.
- Strong attention to detail and analytical skills.
- Proficiency in regulatory information management systems (RIMS) is preferred.
- Strong communication and interpersonal skills for effective collaboration with both internal teams and external regulatory agencies.

**Job Location**:
Dubai

**Salary Range**:
3000-5000

Pay: AED3,000.00 - AED5,000.00 per month



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