Regulatory Affairs – Portfolio Lead

Our client in the pharmaceutical industry is seeking a Regulatory Affairs Portfolio Lead to manage the preparation, compilation and submission of regulatory dossiers and related documentation for pre-registration and post-registration applications. The role is responsible for supporting the timely registration and ongoing regulatory maintenance of pharmaceutical products in accordance with applicable regulatory requirements.

KEY RESPONSIBILITIES

·      Initiate and manage the regulatory registration process for new product submissions.

·      Screen, compile and submit registration dossiers to the relevant Regulatory Authorities within required timelines.

·      Coordinate the collection of dossiers and supporting regulatory data from suppliers.

·      Prepare and submit post-registration updates, variations, resolutions and other required regulatory correspondence.

·      Conduct dossier audits, due diligences and post-registration variations in accordance with current regulatory guidelines and applicable regulations.

·      Maintain effective relationships with Regulatory Authorities and internal and external stakeholders to support regulatory objectives.

·      Manage, audit and support the implementation of regulatory systems.

·      Prepare, review and adhere to SOPs and applicable local regulatory guidelines.

·      Monitor assigned submissions and follow up with relevant health authorities to support timely product registrations.

MINIMUM REQUIREMENTS

·      B.Pharm or Diploma in Pharmacy.

·      Registration with the SAPC.

·      3–5 years’ experience in RA, preferably within orthodox human medicines.

·      Demonstrable experience across the product development, commercialisation and maintenance lifecycle.

·      Sound project management capabilities.

·      Proven ability to consistently deliver to quality, time and cost standards.

·      Knowledge of new and emerging Acts, Regulations and Guidelines relevant to the pharmaceutical industry.

·      Experience using eCTD software

The ideal candidate will have a strong detail, quality and compliance orientation, with excellent analytical, problem-solving, time management and communication skills. They should be a self-starter who can work independently, manage multiple projects simultaneously, understand stakeholder needs and consistently meet strict timelines. The role requires adaptability, teamwork, a strong sense of urgency and the ability to perform effectively under pressure. If you are an experienced RA professional ready to manage pharmaceutical product registrations and regulatory lifecycle activities, apply now using the link below.