Overview
Regulatory Affairs Portfolio Lead Jobs in Johannesburg, South Africa at Unique Personnel (Pty) Ltd
Permanent – Regulatory Affairs Portfolio Lead – Johannesburg – South Africa
Responsibilities:
Manage work streams for and report on the assigned portfolio of products.
Assist with internal product queries from relevant departments.
Assist with external product queries from the SAHPRA, other MRAs, and third-party stakeholders.
Establish regulatory priorities and allocate resources and workloads.
Review regulatory agency submissions of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards.
Conduct artwork reviews and approvals.
Coordinate and submit new product applications in South Africa and other applicable territories.
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.
Prepare registration applications for submission to the regulatory authorities.
Work incollaborationwith internal and external stakeholders to assess regulators’ submission 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.
Provide internal training and mentoring.
Establish and maintain effective relationships with Regulatory Authorities and internal and external stakeholders.
Formulate or implement regulatory affairs systems, policies, and procedures to ensure thatregulatory complianceis maintained or enhanced, including reporting and metrics management.
Support activities such as internal audits or regulatory agency inspections.
Ensure alignment of personal andcompany values.
Minimum Requirements:
Bachelor’s degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council.
3 to 5 years’ experience in Regulatory Affairs, preferably in human medicines.
Demonstrable experience across the product development, commercialization, and maintenance lifecycle.
Soundproject managementcapabilities.
Proven ability to consistently deliver to quality, time, and cost standards.
Experience in the use of CTD software builder and compilation of eCTD applications.
Ability to prioritize and work to tight deadlines.
Systems and operations analysis skills.
Basic cost management skills.
Active learning and 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-solvingand decision-making skills.
Customer relationshipmanagement.
Development of people.
Must demonstrate responsibility, excellence,collaboration, and alignment withCompany values.
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Title: Regulatory Affairs Portfolio Lead
Company: Unique Personnel (Pty) Ltd
Location: Johannesburg, South Africa
Category: Management, Healthcare
