Regulatory Affairs Pharmacist

**Job Advert Summary**:
Provision of a reliable and efficient regulatory affairs service that puts current regulatory and compliance knowledge of the plasma fractionation industry and plasma derived medicinal products to work in attaining the business goals of NBI in the manufacture and sale of safe, quality, efficacious products in accordance with registration commitments, operational requirements and internationally accepted regulatory standards and those accepted by the SAHPRA.

**Minimum Requirements**:

- Bachelor’s Degree in Pharmacy
- Medicines registration and CTD/e-CTD training
- 3 years in the SA pharmaceutical industry in a manufacturing/quality assurance/regulatory environment.
- Understanding of a pharmaceutical quality system, cGMP, GPP principles and pharmaceutical legal requirements.

Preferable:

- International regulatory submissions
- Experience in biologicals medicines manufacturing industry.
- e-CTD submissions

**Duties and Responsibilities**:

- Updating current product dossiers in the appropriate format by reviewing, co-ordinating, and authoring of proposed pharmaceutical, analytical or clinical documentation as required to secure regulatory approval and compliance.
- Sourcing and referring to current regulatory Guidelines in the analysis/or review of amendments/variations in relation to NBI's current or intended practices that impact on the product registration dossiers.
- Evaluating, reviewing and compiling of additional or supportive documentation, based on pharmaceutical; safety; quality and efficacy principles, as requested by the regulators.

**International NBI product regulatory submissions and registrations**
- Keeping updated with international registration requirements and evaluate NBI compliance for pharmaceutical, analytical and clinical aspects and specific requirements.
- Planning and organising the specified documentation and work flow processes such that product submissions and approvals are expedited.
- Evaluating and verifying that the registration information included as part of the registration package is up to date and reflects current NBI and international practice.
- Evaluating, reviewing and compiling of additional or supportive documentation, as requested by the international regulators.

**Regulatory changes with respect to product licensing conditions, standards and compliance**
- Monitoring the SAHPRA and other international regulatory websites (EMEA, FDA, MHRA, and TGA) to keep updated with regulatory changes.
- Attending and participating at various external meetings and training forums to keep abreast with regulatory changes and trends.
- Evaluating and communicating regulatory requirements and standards in order to facilitate change requests and monitoring of the implementation of these changes within NBI.
- Identifying practices which would impact on our licensing conditions and initiate discussions and recommendations with manager for responses or initiating corrective action.

**Regulatory Affairs Administration**
- Updating the paper and electronic databases and filing systems for promotional material and their supportive documentation as required.
- Updating the paper and electronic databases and filing systems for packaging material and their supportive documentation as required.
- Routinely updating and archiving the electronic filing system of all regulatory guidance documents from various authorities.

**Internal and external networking and support**

Internal
- Establishing working relationships with internal staff to facilitate expedited internal reviews, provision of information and comments on proposed dossier amendments.
- Providing in-house training on relevant regulatory and
- pharmaceutical related aspects.

External
- Maintaining relationships with regulatory peers and colleagues for networking.
- Maintaining effective membership with regulatory organisations as required.
- Providing regulatory advice and assistance for internal and external requests in a timely and professional manner.

**Core Competencies**
- Managing Relationships
- Personal Leadership
- Business Impact
- Leading and Influencing Others
- Technical / Professional knowledge and skills
- Planning and organising
- Attention to detail
- Communication (written and verbal)
- Critical thinking
- Analytical/problem solving skills
- Work standards
- Initiative and self
- motivation
- Networking & Liaison
- Inter-personal skills
- Teamwork & Collaboration