Regulatory Affairs Specialist

3 weeks ago

Johannesburg, South Africa iProcess Global Research Inc Full time

JOB SUMMARY

ESSENTIAL DUTIES

Using a broad base of knowledge and understanding of regulatory requirements, assumes major responsibility for one or more major regulatory affairs areas
Identifies and defines contents for Regulatory filings/dossiers. Leads the assembly and creation of these documents for their timely submission to Regulatory authorities.
Maintenance of sometimes complex existing licenses/certificates, product approvals and simple post market notifications
Works with manufacturing, engineering, and other functional groups on Regulatory compliance issues
Applies standard procedure and learned knowledge to develop regulatory solutions of moderate to low complexity within established guidelines. May collaborate with individuals at different levels in solving problems that are routine in nature. Interprets, executes, and recommends modifications to operating policies where appropriate
The effect of Regulatory support offered to internal customers may be critical to the short-term and intermediate objectives of the department

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

Minimum 4 years experience in Regulatory Affairs.

**Skills**:
In depth knowledge of African region regulations and standards
Working knowledge of and ability to prepare regulatory documentation in compliance with regional regulatory requirements
Familiarity with regulatory standards and demonstrates general knowledge with individual products/geographies
Demonstarted ability to author sections of a regulatory submission under supervision, with content review at end
Qualified within the Regulatory function with limited to moderate understanding of the basic principles, theories, practices, and concepts within the Regulatory function
Recognize and awareness of gaps and potentially suggest solutions

Able to identify adequacy of sections and overall content of submissions
Demonstrated ability to communicate effectively both verbally and and in writing
Must be highly skilled in timely and accurate decisions

Demonstrated analytical and creative thinking skills and the ability to solve complex problems

Certificates, Licenses, Registrations

Quality Assurance or Regulatory Affairs Certification (RAC) desired

**Job Type**: Temporary
Contract length: 6 months

Pay: R300.00 - R400.00 per hour

Ability to commute/relocate:

- Johannesburg, Gauteng: Reliably commute or planning to relocate before starting work (required)

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