Regulatory Affairs Pharmacist Specialist
1 month ago
Emporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.
Key Responsibilities:- Manage work streams for assigned portfolios of products and report on progress.
- Assist with internal and external product queries from relevant departments and regulatory authorities.
- Establish regulatory priorities, allocate resources, and workloads.
- Review regulatory agency submissions to ensure accuracy, comprehensiveness, and compliance with regulatory standards.
- Coordinate and submit new product applications in South Africa and other applicable territories.
- Develop regulatory strategies and implementation plans for new products.
- Conduct dossier due diligence to address data gaps.
- Prepare registration applications for submission to regulatory authorities.
- Collaborate with internal and external stakeholders to assess regulators' submission requirements.
- Maintain existing registrations in accordance with relevant legislation, regulations, and guidelines.
- Stay up-to-date with current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.
- Provide internal training and mentoring.
- Establish and maintain effective relationships with Regulatory Authorities and internal/external stakeholders.
- Formulate or implement regulatory affairs systems, policies, and procedures to ensure regulatory compliance.
- Support activities such as internal audits or regulatory agency inspections.
- Ensure alignment of personal and company values.
- Experience in use of CTD software builder and compilation of eCTD applications.
- IT skills.
- Ability to prioritize 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.
- Responsibility, excellence, and collaboration.
Emporium Human Capital is a leading recruitment agency that offers a competitive salary and a dynamic work environment.
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