Regulatory Affairs Manager

Regulatory Affairs Manager (POS24277)

Aeroton

Salary R1m to R1.2 mil per annum

Qualifications

Bachelors 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 medical devices for end-to-end regulatory

activities.

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 MRAs 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 regulators 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 pharmaceutical 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 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