Regulatory Affairs Pharmacist

2 weeks ago

Durban, KwaZulu-Natal, South Africa NBISA Recruitment Full time

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.

MS Office proficiency (Word, Excel, PowerPoint, Outlook)

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, coordinating, 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.
  • Providing pharmaceutical information and assistance required to comply with _ad hoc_ or product specific regulatory requirements, which may be requested from time to time.
  • Identification and updating of changes required for NBI's Site Master File and submission of the updated document.
  • Updating and generating and analysing data from regulatory databases and SAP for generation of internal and external reports and audits as required.
  • Facilitating and assisting with regulatory information for submission of requirements pertaining to clinical trials, pharmacovigilance and other postmarketing requirements.

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.
  • Providing pharmaceutical information and assistance required to comply with _ad hoc_ or product specific international regulatory requirements, which may be requested from time to time.
  • Evaluating, reviewing and compiling country specific labelling requirements for PPMs.
  • Recording, updating and checking a regulatory manual on individual product registration requirements in applicable international countries.
  • Updating and generating and analysing data from regulatory databases and SAP for generation of internal and external reports and audits as required.

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.
  • 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.
  • Assisting other NBI departments by providing regulatory information to support and complement their activities.
  • Providing input into departmental standard operating procedures where required.
  • Identifying impact of new or changes to master documentation on NBI product registration commitments.
  • Evaluating and reviewing promotional material and website information to ensure compliance with the Medicines Act 101 and Marketing Code Authority.
  • Initiation, review and approval of product packaging m

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