Responsible Pharmacist and Head of Regulatory

**BIOVAC** is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive, and meticulous Responsible Pharmacist and Head of Regulatory to join a goal-oriented team. **QUALIFICATIONS NEEDED**: - Degree in Pharmacy. **NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**: - At least 8-10 years of experience in routine, high product volume, commercially established & sustainable biotech/ in a sterile manufacturing company. - At least 5-10 years of experience at the middle to senior management level. - Experience in quality and regulatory compliance within a cGMP sterile manufacturing facility. - Quality and Regulatory compliance knowledge i.e. SAHPRA and WHO. - Experience in quality and regulatory compliance within a cGMP facility. - Business and operational planning. - Program and project management. - Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources. **KEY DUTIES & RESPONSIBILITIES OF THE ROLE**: **Regulatory Affairs Registration**: - Ensure that the department has developed regulatory strategies, implementation plans, and submission of new products and or management of existing products. - Interfaces with internal and external stakeholders, and international regulatory affiliates to understand complex worldwide regulatory approval requirements. - Responsible for compliance with post-market approval regulatory obligations and maintenance of licenses/authorizations for existing products. - Responsible for review/approval of internal specifications, evaluation of changes in products or processes to determine regulatory impact, and identification of Process Excellence improvements. - Ensure that all SAHPRA, SAPC, and other applicable NRA fees are paid timeously. - Ensure that the department has appropriate policies and procedures. - Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes, interprets regulations, and gives regulatory insight, advice, and support to other departments. - Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem-solving. - Ensure artworks for all products comply with product dossiers and relevant regulations. - Oversight of projects and give guidance on regulatory input. - Ensure there is company representation in domestic or international regulatory agencies/boards on major policy matters or decisions regarding company products. - Participate in the development of and implementation of clinical trial protocols. - Ensure that there is regulatory input - into change control, deviation, CAPA, and quality technical agreements. **Pharmacovigilance** - Ensure that the business has a robust pharmacovigilance system with appropriate policies and SOPs. - Maintain awareness and ensure adherence to established and updated local and global processes and guidelines as well as national and international regulations and guidelines for pharmacovigilance. - Ensure PV business continuity and after-hours availability. - Lead and coordinate internal and external PV audits and inspections. - Monitor PV system performance and compliance of partners and distributors. - Maintain expertise in local and international regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country. - Accountable for all strategic PV activities. - Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Biovacs products and to meet regulatory requirements. - Act as the responsible contact person in the region, internally and externally, for safety-related aspects and PV. - Ensure PV processes and procedures are well documented and support compliant regulatory/PV activities. **Responsible pharmacist** - Responsible to ensure that the pharmacy is continuously supervised. - Responsible to ensure that persons being employed in such pharmacy and who provide services forming part of the scope of pharmacy practice of a pharmacist are appropriately registered with the Pharmacy Council. - Responsible to take corrective measures in respect of deficiencies regarding inspection reports of the Pharmacy Council or SAHPRA regulatory audits in terms of the Medicines Act. - Ensure the safe and effective storage and keeping of medicine or scheduled substances in the pharmacy. - Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping, and return of medicines or scheduled substances. - Ensure the promotional material is in accordance with legal requirements. - Sign affidavits for dossier submissions. - Ensure that all printed packaging materials comply with legal requirements. - Initiate and coordinate all recall activiti