Regulatory and Clinical Affairs Manager

SUMMARY:
Our client in the Pharmaceutical Industry, has an opportunity available for a Regulatory and Clinical Affairs Manager in the Pinetown, KZN area.

POSITION INFO:
Education and Experience Requirements:

• B. Pharm degree
• M.Sc. Clinical Pharmacy or equivalent postgraduate degree
• Registered with the South Africa Pharmacy Council (SAPC)
• 5 years’ experience in the SA pharmaceutical regulatory environment AND
• 3 years’ experience with Medicines Information Services
• A minimum of 3 years’ experience at senior management level including leading, mentoring and coaching teams
• A thorough understanding of the requirements of a pharmaceutical quality system and cGMP principles
• Fully proficient in MS Office (Word, Excel, PowerPoint, Outlook)
• Good working knowledge of bibliographic management software Fully proficient in databases such as MS Access, Lotus Notes, InforMED, PCV Manager or similar
• Clinical Trials Knowledge & Experience
• SAP experience will be an added advantage

KPAs:

• Review of regulatory and clinical impact of strategic and business planning processes
• Participate in specific and relevant strategic review teams to provide strategic regulatory intelligence throughout the product life-cycle, including guidance and support for product development from pre-clinical through to registration and product optimisation
• Taking overall responsibility for the regulatory function at the Company
• Conducting dossier due diligence to ensure that all gaps are addressed in preparation for submissions of variations or new registration applications
• Performing regulatory and clinical risk analysis and advising on risk mitigation strategies
• Keeping abreast of local and international pharmacovigilance regulations and practices in order to anticipate changes and proactively integrate these into the Company''s business practices
• Reviewing and approving adverse event procedures, communications and reports with relevant internal and external individuals as well as organisations such as SAHPRA
• Liaising with external consultants in terms of adverse event investigations, when required
• Provision of regulatory guidance with respect to product licensing conditions
• Evaluating, reviewing and approving the clinical and medicines information supplied within the required time frame, in the appropriate format
• Provision of external and internal education and training services
• Conducting clinical trials and post-marketing studies
• Contributing to the regulatory strategy and knowledge to assist stakeholders navigate the challenging regulatory environment
• Attending and providing meaningful input into relevant Pharmaceutical Industry and Medical Advisory forums and groups
• Compiling budgets for annual expenditure and training needs in the department
• Utilising effective staff management practices in supervising and leading staff, and managing staff expectations
• Instituting remedial and corrective action (performance counselling), where appropriate, to optimise performance

Please note should you not receive a response within 7 days of applying, you may consider your application as being unsuccessful.

 

NB! This job is now closed. You can apply for other jobs by uploading your CV.

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