Regulatory Affairs Pharmacist at Ascendis Health

JOB OBJECTIVE:

• Compile and maintain registration documentation ensuring compliance with relevant legislation.
• Provision of technical information and regulatory support to all relevant departments.
• Review and approval of new and amended documentation, including artwork.

TASK DESCRIPTION:

• Create, update, submit and maintain product dossier registration documentation in accordance with the applicable regulations which includes translating regulatory requirements into practical, workable submission plans and to develop and maintain timelines.
• Develop and maintain current regulatory knowledge.
• Acquire published new or amended acts, regulations, bills and notices relevant to the industry.
• Identify Standard Operating Procedures and documentation that may be affected by new or amended legislation.
• Convey the implications of new legal requirements to the Responsible Pharmacist and Head of Regulatory.
• Supply technical information and registration support to the relevant departments and identify deviations from legislation and recommend corrective action.
• Ensure that cGMP (current Good Manufacturing Practice) is maintained for all processes and products.
• Collect all the information and specifications required for dossier compilation.
• Collect technical information relating to finished products during new product development (NPD) and to be part of the New Product Development process.
• Write clear, accessible product labels, professional information, and patient information leaflets.
• Ensure that Quality standards are maintained during dossier creation and propose improvements.
• Provide thoughtful and accurate comments during document review mindful of regulatory requirements.
• Finalise and present to a RA Pharmacist or Responsible Pharmacist a completed dossier in the required format for final approval.
• Where delegated by the Responsible Pharmacist, approve and sign dossiers for submission to SAHPRA.
• Perform regulatory audits on product dossiers.
• Perform peer reviews on colleagues’ dossiers.
• Migrate to and maintain dossiers on the DocuBridge system.
• Review all master documentation sent for approval by third party manufacturers.
• Ensure the regulatory compliance, and approve, artwork and marketing material according to the relevant Standard Operating Procedures.
• Initiate and facilitate change control process in according to the relevant Standard Operating Procedure.
• Assist with the initiation and monitoring of product stability testing and data, and incorporation into dossiers, when required.
• Assist with the adverse drug reaction and pharmacovigilance processes within the department
• Assist with customer enquiries where required.
• Be certified with the Marketing Code Authority and advise relevant departments on the requirements.
• Without detracting from specific tasks and duties referred to in the job description, comply with any reasonable requests or instructions from the Responsible Pharmacist and Head of Regulatory related to company functions from time to time.

SUPERVISION EXERCISE:

• There are no direct reports in this position, however supervision of regulatory support staff may be required.

INHERENT REQUIREMENTS:

• Attention to detail
• Self-motivated individual
• Ability to work under pressure and complete tasks against deadlines
• Excellent written and verbal communication skills
• Excellent communication and interpersonal skills within a team context
• Ability to multi-task and handle a few tasks simultaneously
• Provide leadership, guidance, and management as required
• Act with integrity – honour commitments, take responsibility for decisions, and behave consistently
• Maintain appropriate communication within and between the different functional areas in the broader team

QUALIFICATION AND SKILLS:

• Bachelor of Pharmacy
• 5-10 years' experience in the pharmaceutical/CAMS industry (Production/Quality Assurance/Regulatory)
• Good working knowledge of MS Office (Excel, Word, Adobe Pro, Power point, etc.) and Outlook
• Working knowledge of DocuBridge – advantageous
• Must have the ability to meet deadlines
• Sound decision-making ability
• Operational and executional excellence
• Results orientated
• Strong sense of accountability
• Proven relationship building and stakeholder management