Regulatory Affairs Officer

4 days ago

Hidd, Bahrain GULF BIOTECH BSC CLOSED Full time

Main Responsibilities:

- Ensure adherence to local and international regulatory guidelines.
- Handle CTD and eCTD submissions for product registrations.
- Supervise product registration procedures and engage with regulatory bodies.
- Proficiency in utilizing eCTD publishing software for submissions.
- Develop regulatory strategies in coordination with cross-functional teams.
- Maintain precise regulatory documentation and uphold quality standards.
- Keep abreast of regulatory modifications and industry best practices.
- Coordinate with internal departments for regulatory assistance.
- Conduct training and offer guidance to junior regulatory personnel.
- Support audits, inspections, and regulatory project management activities.

**Requirements**:

- Languages proficiency :English and arabic (Speaking,Reading and writing)
- Bachelor in Pharmacy
- 4-6 years in sterile product registration and regulatory operations section
- Advanced regulatory affairs certification is a Bonus
- Strong communication skills

**SALARY TO BE DECIDED AFTER THE INTERVIEW**

Pay: From BD400.000 per month

**Education**:

- Bachelor's (required)

**Experience**:

- Regulatory affairs: 4 years (preferred)

**Language**:

- arabic and english (required)

License/Certification:

- NHRA license (preferred)

Application Deadline: 30/09/2024

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