Regulatory Affairs Specialist
Regulatory Affairs Specialist
Posted on :
04-06-2025
Employer Active
1 Vacancy
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Job Description
What Youll do
- Preparation and submission of new Marketing Authorisation applications
- Maintenance of approved marketing authorisation dossiers including submission of variations renewals and follow-up measures.
- Preparation of the above submissions in collaboration with other departments and partner companies.
- Preparation of responses to queries from regulatory authorities and partner companies.
- Publishing of regulatory submissions using relevant Manager Software.
- Review and approval of product artworks to ensure compliance with the relevant MA.
- Interactions with management and partner companies and provision of documentation required to support the MAs they have responsibility for.
- Regulatory compliance activities and GMP documentation (specifications batch records etc.).
- Maintenance of Wholesale Distribution Authorisation.
- Maintenance of Regulatory forms logs and databases with up-to-date regulatory information.
GMP
- Cognisance and compliance with all the necessary elements of process paperwork including Standard Operating Procedures system logs stock control systems machine logs process documentation and specifications.
- Responsible at all times for plant and process hygiene within the area of operation.
- Vigilance for product or process defects and the reporting of same.
Qualifications :
- Level 7 or Bachelors is required.
- 2 Years experience in a similar role.
- Preferably working knowledge of eCTD manager software.
- To be vigilant when operating machinery and comply with all safety mechanisms.
- Faulty or unsafe equipment is efficiently reported and rectified.
- Wearing correct gear and equipment necessary for operation at all times.
- Co operate with training and screening by the company representing SGS in a professional light.
- Excellent communication and organisation skills due to the high volumes of documentation.
Additional Information :
We offer you:
An opportunity to develop and international career in a friendly supportive approachable working environment with a down-to-earth culture. Continuous learning with the chance to expand and enrich your career with our dedicated training team to support your career development opportunities across SGS.
- An attractive compensation and benefits package including
- Bonus
- Healthcare
- Pension
- Enhanced annual leave
To apply please submit your CV.
We are an equal opportunity employer and value diversity at our company.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
Key Skills
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