Senior/principal Regulatory Writer

2 days ago


Cape Town, South Africa Hobson Prior Full time

Hobson Prior are currently looking for a Senior/Principal Regulatory Writer to join a fantastic CRO on a permanent basis with the ability to work remotely from anywhere within South Africa. Our client is focused on resolving important decisions and crucial points in the product lifecycle.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For this role, you will be involved in client services and will partake in tactical planning of regulatory proposals.
- Guide the planning and distribution of regulatory proposals and any other large regulatory projects.
- Review scientific data objectively to document outcomes and scientific notions in a concise and precise manner.
- Any other assigned duties.

**Key Skills**:

- A proactive approach with well-advanced project management abilities.
- A confident individual with efficient social capabilities.

**Requirements**:

- Experience in drug development pertinent to the area of regulatory writing.
- Educated to a degree level in a suitable scientific topic with a scientific background.
- At least 3 - 5 years of regulatory writing experience.
- Familiarity with Clinical documents: clinical study procedures, clinical study reports, patient narratives, site operations manuals, informed consent papers, Investigator's Brochures, General Investigational Plan, Patient Lay Summaries, Modules 2.5, 2.7.3, and 2.7.4 of IND, IMPD and NDA proposals.
- Fluency in the English language.
- Comprehension of clinical development and ICH regulations for regulatory reports.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.



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