Industrial Pharmacist and Regulatory Manager

7 months ago


Alberton, South Africa Air Liquide Full time

**How will you CONTRIBUTE and GROW?**:

- Responsible for the activities associated with the approval of a product including such activities as development, coordination, and submission of responses to Regulatory Authority inquiries.
- Monitor, follow up and report on progress of regulatory submissions and ensure registration, planning, and tracking of regulatory database management.
- Provide consultative support to product marketing teams on business decisions with regulatory implications.
- Review promotional material to ensure that it is in compliance with the company's standards and that of the MCC and the Code of Marketing practice.
- Involved in the negotiation of first approval labeling with regulatory authorities, and labeling revisions over the product's lifecycle.
- Provide world-class medical information (medinfo) within agreed timelines and release medical products onto the market.

**__________**:
**Are you a MATCH?**:
**Requirements**:
**Education**
- B.Pharm degree
- Currently registered with the SA Pharmacy Council

**Experience**
- At least 3 years experience in Regulatory Affairs
- At least 2 years in production or quality assurance
- Knowledge of Dossier compilation & Conversions to eCTD
- Knowledge of Medical information/pharmacovigilance
- Knowledge of ISO9001

**Our Differences make our Performance
**At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.



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