Regulatory Affairs Pharmacist

**Job description - Regulatory Affairs Pharmacist**

**Purpose**:
Responsible to the South African Health Products Regulatory Authority (SAHPRA) and the South

African Pharmacy Council for the products of the company
- Applicant and Regulatory Compliance to Act 101 of 1965 and Act 53 of 1974.
- Management of the Regulatory activities for the company

**Roles and Responsibilities**:

- Quality Management Systems o initiate and co-ordinate all recall activities, o CAPA reports o Risk Management Plans
- Standard Operating Procedures
- Project Management
- Product Development and Compliance
- Product Complaints
- Final Product Release to Market (FPRR)
- Liaise closely with outsourced regulatory consultant to ensure all activities are on track with agreed plans.
- Undertake regular follow up and project meetings with regard to the outsourced regulatory activities.
- Appropriate planning and implementation of regulatory strategy with appointed third party vendors and regulatory consultants, for both existing and new products.
- Undertake regulatory compliance audits as the representative of the company and ensure these are closed out and filed.
- Elevate any serious quality issues to the Directors, CEO, Quality, and Pharmacovigilance for action.
- Ensure signature of Technical Quality Agreements (TQA's) and Safety Data Exchange Agreements (SDEA's) by third party vendors.
- Manage any other regulatory and quality matters that arise and act upon any other reasonable instruction to ensure an efficient and effective work environment.
- Receive new dossiers for submission and ensure subsequent submission
- Support the supply of products to third party distributors, assisting with regulatory requirements, for the importation and distribution of products.
- Communication and coordination between the appointed third party vendors and the Pharmacovigilance Officer, where applicable.
- Assist with the launch of new products, including packaging (artwork, Pl and PIL) review and sign off; o Master Artwork: Development, version control, sign off, filing and distribution o Barcode allocation for packaging components (done in conjunction with the Regulatory Assistants)
- Ensure information included in the Pharmacovigilance (PV) section for products launched.
- Ensure distributors and their clients are adequately licensed/registered to sell products.
- Keep employees updated as to Marketing requirements and assist with these requirements when global strategies are being developed.
- Liaise with Quality and Pharmacovigilance to understand the status of products and feedback to the Company.
- Ensure that the regulatory strategy is fully integrated with the commercial and supply chain strategies.

**Qualifications **& **Experience**:

- 3-5 years Pharmaceutical Industry experience
- Pharmacy (B.Pharm) Degree
- Good understanding of International Pharmaceutical Best Practice
- Experience and understanding of the South African Regulatory Requirement
- Exposure and experience in dealing with multiple markets directly

**Key Attributes**:

- Problem solving skills;
- Accuracy and attention to detail;
- Effective organization skills and ability to prioritize;
- Ability to work under pressure and to tight deadlines;
- Ability to work in a fast paced international environment;
- Ability to manage projects in a matrixes team environment and with both internal and external partners;
- Willing to travel;
- Strong team player.

Ability to commute/relocate:

- Cape Town, Western Cape: Reliably commute or planning to relocate before starting work (preferred)

**Education**:

- Bachelors (preferred)

**Experience**:

- Regulatory: 3 years (preferred)