Regulatory Affairs Portfolio Lead, Midrand

Job Purpose Support the Regulatory Affairs team to provide superior Regulatory services to relevant departments within the company and with external Partners and Principals, and to control and manage a portfolio of product outputs. To ensure legal and regulatory compliance with the relevant medicine Regulatory Authorities (country-specific where applicable), Medicines and Related Substances Control Act, and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

Key Job Outputs

Manage work streams for, and report on the assigned portfolio of products:

Assisting with internal product queries from relevant departments

Assisting with 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

Artwork reviews and approvals

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

Conduct dossier due diligence to ensure all data gaps are addressed

Prepare the registration applications for submission to the regulatory authorities

Work in collaboration with internal and external stakeholders to assess the regulator's 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.

Internal training and mentoring

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, including reporting and metrics management.

Support activities such as internal audits or regulatory agency inspections

Ensure alignment of personal and company values.

Qualifications / Experience

Bachelor's degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council

3 years' experience in Regulatory Affairs, preferably in human medicines with experience across product development, commercialisation and maintenance lifecycle

Demonstrable experience in quality-driven processes such as risk management, change control, deviations, CAPAs, root cause investigations

Additional experience in African territories is preferable

Sound project management capabilities, with an understanding of the medicines value chain

Proven ability to consistently deliver to quality, time and cost standards

Core competencies

Experience in the use of CTD software builder and compilation of eCTD applications.

Ability to prioritise and work to tight deadlines

Systems and operations analysis

Basic cost management skills

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

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