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Regulatory Affairs Manager
2 weeks ago
Job Number
- 72786
Job Type
- Permanent
Job Title
- Regulatory Affairs Manager
Computer Skills
- Ms Office
Industry
- Manufacture
City
- Johannesburg (Incl. Northern Suburbs)
Province
- Gauteng
Reporting to Head:
Regulatory Affairs
Job purpose:
- Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs.
Key Job Outputs
- Manage work streams for
- Assisting with internal product queries from relevant departments
- Assisting with external product queries from the SAHPRA, other MRA's and thirdparty stakeholders
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Conduct dossier due diligence to ensure all data gaps are addressed
- Work in collaboration with internal and external stakeholders to assess regulator's submissions requirements
- 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 values
Inherent Requirements
Qualifications/Experience
- Bachelor's 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
Core competencies
- IT skills
- Leadership skills
- 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 decisionmaking skills
- Customer relationships
- Development of people
- Must demonstrate responsibility, excellence and collaboration and align with Company values
What Qualification
- Degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
Minimum Qualification
- Bachelors
Status
- Available
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