Regulatory Affairs Assistant

2 weeks ago


Abu Dhabi, United Arab Emirates Wellpharma Medical Solutions Full time

**Role and responsibilities**:

- Prepare submission of registration, renewal, and variation documents in eCTD format as per the GCC and respective authority’s guidelines.
- Assist in obtaining and maintaining authority's approval for drugs in several countries.
- Coordinate and cooperate with multiple departments for document preparation, information management and file maintenance.
- Regular check of the Dubai Drug Code status for the products and ensure their timely renewal.
- Keep up to date with the national and regional legislations and guidelines.
- Follow up with the local authorities and the agents in different countries for the variation and registration approvals.

**REQUIREMENTS**:

- Bachelor's degree in biochemistry, biological sciences, chemistry, pharmacy, pharmacology.
- 1-2 Years experience in Regulatory Affairs
- Written and Oral communication skills
- Time management skills
- Attention to Details
- Organizational Skills
- IT skills (Microsoft word and excel)
- Capable of working in an environment with competing priorities and strict timelines.

**Salary**: AED3,000.00 - AED3,500.00 per month

Ability to commute/relocate:

- Abu Dhabi: Reliably commute or planning to relocate before starting work (required)

Application Question(s):

- Can join immediately?

**Experience**:

- Regulatory Affairs: 1 year (preferred)



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