Job Description

• Bachelor's Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council
• +-5 years' experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and

devices for end-to-end regulatoryactivities.

• 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
• Good Manufacturing Practices (GMP)
• Pharmaceutical production experience or exposure to supplement regulatory knowledge.

Key Job Outputs

• Manage work streams for- and report on the assigned portfolio of products:
• Internal product queries from relevant departments
• External product queries from the SAHPRA, other MRA's and third-party 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
• Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to
• Develop regulatory strategies and implementation plans for the preparation and submission of new products, with a focus on complementary

medicines and medical devices.

• Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines

and other human medicines.

• Prepare the registration applications for submission to the regulatory authorities
• 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

for variations (CMC & Labelling), Renewals, Artwork updates etc.

• Update and maintain databases, trackers and systems for all regulatory related activities.
• Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained.
• Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the

industry. * Internal training and mentoring of peers when required.

• 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.
• Support activities such as internal audits or regulatory agency inspections
• Ensure alignment of personal and company values
• Core competencies
• Experience in use of CTD software builder and compilation of eCTD dossier applications.
• IT skills including Microsoft Office
• 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

Similar jobs you might be interested in:Location: Aeroton
Salary: R100k - 120k per month
regulatory affairs manager, regulatory affairs pharmacist
1 day agoLocation: Olifantsfontein
Salary: R740k - 800k per year
regulatory Pharmacist
6 days agoLocation: Aeroton
Salary: R1.5m - 1.7m per year
regulatory affairs manager
6 days agoLocation: Olifantsfontein
Salary: R740k - 800k per year
regulatory Pharmacist
8 days agoLocation: Olifantsfontein
Salary: R740k - 800k per year
regulatory Pharmacist
13 days agoLocation: Aeroton
Salary: R1.5m - 1.7m per year
regulatory affairs manager
13 days agoLocation: Midrand
Salary: 900 000 Annually
Pharmaceutical Client looking for a regulatory affairs manager to support the regulatory team and 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.
16 days agoLocation: Aeroton
Salary: R1.5m - 1.7m per year
regulatory affairs manager
27 days agoLocation: Olifantsfontein
Salary: R740k - 800k per year
regulatory Pharmacist
27 days agoLocation: Aeroton
Salary: R1.5m - 1.7m per year
regulatory affairs manager
34 days agoJobseekersRecruiterGeneralxc3x82xc2xa9 Copyright 2024 Executive Placements. All Rights Reserved.Create an email alert for Regulatory Affairs Manager jobsWhat:Where:Email:Create Email AlertYou can cancel at any time. We will not spam you. By giving us your email address your agree to our and You agree to receive job alert emails from executiveplacements.com and/or our sister site jobplacements.com.

ExecutivePlacements.com