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Regulatory Affairs Manager
3 months ago
- Manage work streams for- and report on the assigned group
- Co-ordination and submission of new product applications in South Africa and other applicable territories.
- Ensure the maintenance and/or update of existing registrations in accordance
- with the relevant legislation, regulations and guidelines
- Maintain current knowledge of relevant Acts, Regulations and Guidelines
- pertaining to the pharmaceutical industry.
- Internal training and mentoring
- Establish and maintain effective relationships with Regulatory Authorities,
- internal and external stakeholders
- Formulate or implement regulatory affairs systems, policies and procedures to
- ensure that regulatory compliance is maintained or enhanced.
- Manage activities such as internal audits or regulatory agency inspections
- Ensure alignment of personal and company value
Core competencies
- Experience in use of CTD software builder and compilation of eCTD application
- will be an advantage.
- IT skills
- Leadership skills
- management of personnel resources
- Ability to prioritise and work to tight deadlines
- Systems and operations analysis
- Basic cost management skills
- Active learning
- Strategic thinking
- Ability to cope with a high degree of complexity and change
- Cross Functional skills: Ability to network, liaise and negotiate with others
- Ability to set standards and objectives and monitor progress
- Complex problem solving and decision-making skills
- Customer relationships
- Development of people
- Must demonstrate responsibility, excellence and collaboration and align with
- Company values
Qualifications
- Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
- Minimum of 5 years experience in Regulatory Affairs, preferably in human medicines.
- Demonstrable experience across the product development, commercialization and maintenance lifecycle
- Sound project management capabilities
- Proven ability to consistently deliver to quality, time and cost standards