Regulatory Affairs Pharmacist - OTC

Regulatory Affairs Pharmacist OTC POS24203

Based: Midrand

Salary: R750K

Qualifications/experience

Bachelors 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

Sound project management capabilities

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

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 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

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 regulators submissions 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.

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 applications.

IT skills

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

Interested parties who meet the above requirements must email

Closing Date: 25 July 2024