Job Description

To support the regulatory team in providing superior regulatory services to relevant departments within the company and with external partners and principals, as well as controlling and managing portfolio outputs.To ensure legal 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.Responsibilities:

• Ensure timeous initiation and management of the registration process for new product submissions
• Ensure approval of registration applications of all medicines with the relevant authorities
• Completes specific pre-registration activities including receipt, screening, compilation and timeous submission of dossier/s Regulatory Authority
• Ensures that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable registrations
• Ensures that required standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers are followed after signing of appropriate agreements
• Ensure the maintenance/update of registrations in accordance with the relevant legislation, regulations and guidelines
• Receives, prepares and submits all applicable updates, variations, resolutions and any other correspondence required by the Regulatory Authority
• Completes dossier audits of Registered Products for the assigned products
• Conducts dossier due diligences, and post-registration variations for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and applicable Regulations within the specified timelines in order to support the business and strategic company objectives
• Establish and maintain effective relationships with Regulatory Authorities
• Manages relationships with the Regulatory Authorities to ensure more effective streamlining of the companys applications when required
• Building sustainable relationships with internal and external stakeholders to achieve regulatory goals
• Effectively managing, auditing and implementation of Regulatory systems
• Prepare, review and adhere to Standard Operating Procedures (SOPs) and local Regulatory Guidelines
• Ensure alignment of personal and company values

Competencies:

• Attention to detail
• Knowledge of the Regulatory requirements for medical products in South Africa and other applicable territories
• Project management skills
• Leadership skills
• Ability to prioritise and work to tight deadlines
• Systems approach
• Cross-functional skills: Ability to network, liaise and negotiate with others
• Ability to set standards and objectives and monitor progress
• Problem-solving and decision-making skills
• Sound project management capabilities

Qualifications and Requirements:

• Bachelors degree in Pharmacy and registered with the South African Pharmacy Council
• 1-2 years experience in Regulatory Affairs, preferably in orthodox, human medicines
• Demonstrable experience across product development, commercialization, and life-cycle maintenance.
• Sound project management capabilities
• Proven ability to consistently deliver quality, time and cost standards
• Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
• Experience in the use of CTD software builder and compilation of eCTD applications will be an advantage such as docuBridge

Candidates that meet the criteria may apply via this portal or via www.mnarecruitment.com
Should you not receive feedback within 7 days, please accept your application as unsuccessful

MNA Recruitment