Responsible Pharmacist and Head of Regulatory

5 months ago

Cape Town, South Africa Biovac Full time

**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

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