Registration planning and business support

Implement registration plan and business support for allocated products

• Implement the registration business plan for regulatory affairs that reflects the business objectives of AstraZeneca SA and aligns with brand marketing strategies; and delivers business critical regulatory needs.
• Robust mitigation plans in place to engage Regulatory authorities when earliest signs of delay emerge.
• Provide regular feedback to Regulatory Affairs Manager, marketing and sales teams on the regulatory submission progress of specific products and ensure support needed to drive performance in their respective departments.
• Proactively identify issues and manage risk taking appropriate action, as required on regulatory submission in collaboration with Regulatory Affairs manager, and identify and drive ongoing improvements.

Good Regulatory Practice (GRP)

Implement GRP standards in the following process areas:

• Marketing Authorisation Applications
• License maintenance
• Submissions compilation and dispatch to Health Authority
• Management of Regulatory Knowledge (including Regulatory Product Knowledge and Regulatory  Status Information)
• Labelling & Artwork Management
• Robust Health Authority interactions
• Ensure an “inspection-ready” Quality System is in place, providing evidence that there are mechanisms in place to ensure that licence to operate regulatory activities are being met in accordance with legislation and AstraZeneca GRP procedures.
• To track and manage all GRP activities and report any non-compliances to the GRP lead.
• To ensure that all local SOPs are updated in line with global SOPs.
• To monitor GRP progress and initiate improvement plans for the SA QMS.
• Complete training in line with the training matrix relevant to job profile/description.

As Deputy Responsible Pharmacist in the absence of the Responsible Pharmacist ensure that the Marketing company is in compliance with Act 101 and the Pharmacy Act 53 of 1974

• Ensure continuous supervision of the pharmacy;
• Have appropriate qualifications and experience in the services being rendered by such pharmacy;
• Ensure that person employed in such pharmacy and who provide services forming part of the scope of practice of a pharmacist are appropriately registered with the council;
• Notify council immediately upon receiving knowledge that his/her services as responsible pharmacist have been or will be terminated;
• Take corrective measures with respect to deficiencies in inspection reports in terms of the Medicines Act.
• Ensure that unauthorized persons do not obtain access to medicines or scheduled substances or the pharmacy premises outside of normal trading hours.
• Establish policies and procedures for the employees of the pharmacy with regard to the acts performed and services provided in the pharmacy;
• Ensure the safe and effective storage and keeping of medicine or scheduled substances in the pharmacy under his or her direct personal supervision;
• Ensure correct and effect record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances in the pharmacy under his or her direct personal supervision;
• Ensure responsibility of co-coordinating the adverse event reporting service;
• Ensure that the Promotional Affairs Pharmacist or a Senior Official of the company who is a Medical Practitioner approves all advertising and promotional material;
• Initiate and co-ordinate all recall activities, which should involve the head of Quality Management;
• Ensure that a letter of authorization to communicate with SAHPRA, signed by the CEO, be submitted to the SAHPRA;
• Control the manufacturing or distribution of medicines, scheduled substances or medical devices in terms of the provisions of the Medicines Act, 1965;
• Ensure that there is compliance with Good Pharmacy Practice as published by the Pharmacy Council;
• Be part of the decision making process affecting the pharmacy business;
• Supervise every pharmacist appointed by the owner of a pharmacy business, if applicable;
• Ensure that the pharmacy owner complies with all the conditions of:
• ownership of such pharmacy business
• registration of the pharmacy
• Ensure that no person is appointed to perform any act falling outside the scope of practice of the category in which such person is registered or which he/she is not authorised to perform in terms of the Pharmacy Act, 1974 (Act 53 of 1974);
• Report in writing any non-compliance with the Pharmacy Act to the management of such pharmacy business and furnish Pharmacy Council with a copy thereof;
• Not introduce or carry out any instruction or order of management with regard to the pharmacy business of the pharmacy owner which could amount to a contravention of legislation applicable to such pharmacy business; and

Be responsible to the SAHPRA for compliance with the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) relating to the sale, control of the manufacturing and distribution of medicines, scheduled substances or medical devices.

Regulatory process for allocated products

• Ensure that the regulatory processes for allocated products are performed timeously in line with GRP.
• Marketing Authorisation Applications
• -Submit Marketing Authorisation Applications to Health Authorities according to local guidelines and GRP, in the shortest possible time based on business priorities. 
• Licence maintenance:
• Ensure all post approval product maintenance activities including CMC variations, package insert safety updates, new indications, technical changes to the label or the packs, and post approval commitments are submitted, are submitted and approved.
• Ensure all product dossiers are converted to CTD format in line with legislative requirements.
• Submissions compilation and dispatch
• Complete due diligence of registration documents/ dossiers.
• Obtain relevant information from key Global RA and resolve queries to ensure delivery of submissions within agreed timelines.
• Labeling & Artwork Management:
• Ensure labeling and artworks are effectively managed through the AstraZeneca Global Labeling Business Process using the GAZELLE system.
• Health Authority interactions
• All communication with Health Authority regarding submissions, product registration or maintenance throughout the life cycle of the product is managed

Established stakeholder relationships and consolidated regulatory role

• Build and maintain relationships with Health Authorities to influence regulatory timelines and outcomes.
• Ensure early interventions as per historical timelines.
• Regular follow up with key Health Authority personnel on the status of all outstanding approvals.
• Regular follow up with Global RA teams on outstanding responses to Health Authority recommendations.
• Communicate regularly with marketing company colleagues regarding regulatory requirements and objectives and share best practice ideas.
• Represent AstraZeneca to key players and other identified stakeholders.
• Attend local trade association meetings in order to network with other Pharmaceutical Companies for updates to regulatory requirements and best practices.

Personal effectiveness

• Maintain current knowledge of AstraZeneca policies and procedures, standards of practice (SOP's) and Health Authority legislative requirements.
• Achieve competence in prescribed skills and knowledge.
• Identify developmental needs and locate appropriate learning resources.

Alignment of personal values with company values

• Facilitate the development of a diverse and harmonious working environment and actively encourage the development of the AZ culture.
• Display and develop AstraZeneca leadership capabilities.

GAZELLE Local Process Expert

To effectively manage the GAZELLE system.

• Training:  Delivery of end user training (process and system) in accordance with respective training material
• Governance: Managing local GLBP and supporting system implementation and monitoring local skills
• User support: 1st line support for local users
• Provide expert advice to  local users on process and supporting system
• Respond and resolve end user problems
• Escalate remaining issues (process and system) via the established support model
• Improvements: Identification of opportunities for process and system improvements

Education, Qualifications, Skills and Experience

Essential

• B.Pharm/ Dip. Pharm /B.Science degree.

• Registered Pharmacist.

• Proven 5 years regulatory experience in pharmaceutical dossier preparation and submission in SA markets, in an ethical pharmaceutical environment.

• Computer literacy in MS Office Suite

• Excellent written and verbal communication skills

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.