pharmaceutical company has a vacancy for a Head of Medical Affairs. Job Purpose: Develop and maintain in depth area(s) through attendance / participation at key internal meetings/training sessions, relevant congresses self-study of the national/international literature. Provide expert medical/scientific advice for assigned development and medical and scientific accuracy of core dossiers generated by the medical department (i pricing and reimbursement dossiers, HEOR dossiers, medical information packs, clinical expert reviews etc
assigned portfolio of products: Assisting with internal product queries from relevant departments Assisting regulatory authorities Work in collaboration with internal and external stakeholders to assess regulator's Guidelines pertaining to the pharmaceutical industry. Internal training and mentoring Establish and maintain Authorities, internal and external stakeholders Formulate or implement regulatory affairs systems, policies maintained or enhanced. Support activities such as internal audits or regulatory agency inspections Ensure
Senior Regulatory Affairs Pharmacist Industry: Pharmaceutical Location: Midrand Equity Requirement: EE gaps are addressed Work in collaboration with internal and external stakeholders to assess regulator's Authorities, internal and external stakeholders Formulate or implement regulatory affairs systems, policies Council 3 to 5 years' experience in Regulatory Affairs, preferably in human medicines Demonstrable experience
Regulatory Affairs Manager Industry: Pharmaceutical Location: JHB Equity Requirement: EE Lead the Regulatory the assigned group of portfolios Assisting with internal product queries from relevant departments Assisting new products Formulate or implement regulatory affairs systems, policies and procedures to ensure that Council Minimum of 5 years' experience in Regulatory Affairs, preferably in human medicines. Demonstrated experience
Regulatory Affairs Scientist Industry: Pharmaceutical Location: JHB Equity Requirement: EE Large Pharmaceutical Manufacturing facility seeks to employ a Regulatory Affairs Scientist. The following applies: Key Responsibilities: Minimum 1-2 years' solid experience in Regulatory Affairs, preferably in orthodox, human medicines Demonstrable
Regulatory Affairs Pharmacist (POS24192)
Area; Aeroton
Salary R750 800k
Purpose Council
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Regulatory Affairs Manager (POS24277)
medicines and medical devices.
a Regulatory Affairs/Quality Assurance Pharmacist to join their team. Regulatory Affairs (RA): Submit system for Act 101 products. Integrate ISO 13485 medical devices into the QMS. Co-audit local audits, generate/review training. Act as an authorized representative for medical devices. B. Pharm degree with at least two years
experience of working in several groups in regulatory affairs or experience at a health authority
Knowledge
management of a skill group such as CMC, Regulatory affairs project management, etc.
Responsible for
across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions
Regulatory Affairs Manager (POS24191)
Area: Aeroton
R1 Council