Regulatory Affairs Pharmacist 101 views

Purpose:

A reliable and efficient Regulatory Affairs Pharmacist 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 the organisation 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.

Key Job Outputs:

National product regulatory submissions and applications

• 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 the company’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
• Evaluating, reviewing and compiling of additional or supportive documentation for resolving issues identified as part of new medicine applications
• Providing pharmaceutical information and assistance required to comply with ad hoc or product specific regulatory requirements, which may be requested from time to time
• Correctly and efficiently utilise the required software and electronic systems to facilitate submissions and applications as required
• Supporting pharmaceutical, analytical or clinical compilations for miscellaneous requests to SAHPRA, such as exemptions, Section 21 applications etc.
• Identification and updating of changes required for the company’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
• Co-ordinating the regulatory administrative aspects that include inter alia, payment of fees, GMP certificate applications and report submissions
• Organising work flow processes and compiling documentation for approval of new product applications
• Facilitating and assisting with regulatory information for submission of requirements pertaining to clinical trials, pharmacovigilance and other post-marketing requirements.
• Serve as back up to other regulatory pharmacists to sign the dossier submissions and other applications if required

International company product regulatory submissions and registrations

• Keeping updated with international registration requirements and evaluate the company’s 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 company and international practice
• Evaluating, reviewing and compiling of additional or supportive documentation, as requested by the international regulators
• Evaluating, reviewing and compiling of additional or supportive documentation for resolving issues identified as part of new medicine international applications
• 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
• Updating company’s international registrations by compiling and submitting updated applications as and when they are affected by changes to the local registration
• 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
• Co-ordinating the regulatory administrative aspects that include inter alia, payment of fees, GMP certificate applications and report submissions

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 change
• 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 the company
• Identifying practices which would impact on our licensing conditions and initiate discussions and recommendations with manager for responses or initiating corrective action
• Assisting other company 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 the company 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 material (PPM) in compliance with regulatory requirements
• Facilitating the acquisition/ requisitions and renewals of regulatory resources in a timely manner

Regulatory Affairs Administration

• Updating the paper and electronic databases and filing systems for regulatory submissions, applications and their supportive documentation as required
• 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
• Documenting all verbal and non-formal correspondence for future reference
• Maintain and facilitate archiving of regulatory documentation as required
• Electronic filing and updating of PPM within the company with the correct system
• Implementing design, population and maintenance of any internal databases that are deemed necessary
• Updating external databases and forms that directly impacts on regulatory information
• Processing of requisitions for procurements and payments

Internal and external networking and support

• 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
• 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:

• Understanding of a pharmaceutical quality system, cGMP, GPP principles and pharmaceutical legal requirements
• MS Office proficiency (Word, Excel, PowerPoint, Outlook)
• International regulatory submissions
• E-CTD submissions
• Performance management
• Leading and influencing others
• Managing Relationships
• Business Impact
• 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

Qualifications

• Bachelor’s Degree in Pharmacy
• Medicines registration and CTD/e-CTD training

Experience:

• 3 years in the SA pharmaceutical industry in a manufacturing/quality assurance/regulatory environment
• Regulatory experience and skills in the compilation, preparation, submission and maintenance of dossiers and new drug applications
• Experience in biologicals medicines manufacturing industry

Salary:   Market related