Regulatory Affairs Manager

SUMMARY:
Regulatory Affairs Manager, regulatory affairs pharmacist

POSITION INFO:

Regulatory Affairs Manager (POS24277)

Aeroton

Salary R1m to R1.2 mil per annum

Qualifications

• 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 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 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 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