RA Systems and Processes Scientist (AA) - CPT or JHB

SUMMARY:
Support the RA Systems and Processes Manager by assisting in the SAGA RA Systems & Processes

POSITION INFO:

Job Specification

Related to tracking and tracing; New Product Submissions, New Product Registrations, Life-Cycle management, and overall compliance within the department by ensuring that all processes and systems are in place to facilitate high quality, timeous submissions and responses are submitted to all Health Authorities

Provides regulatory intelligence to Client''s SAGA RA Managers/ Executives/ RA SAGA Director and CEO as needed related to Systems and Processes and data Analytics

Participates in the Regulatory intelligence forum and advising on changes relating to systems and processes within the current regulatory landscape

Ensures Central Dossier and the Life cycle management registration activities are reported regularly

Attends and assists with the management of meetings within each team to ensure on-time delivery of all objectives per team (bi-weekly meetings/ Monthly Governance Deck/ RA Monthly reports/ MBR/ IPD/ Launch readiness)

Ensures on-time reporting and minutes are available for the SAGA RA Director and CEO ahead of Directors meets

Ensures any gaps in SAGA processes are identified and closed through cross-functional discussions and solutions

Ensure ongoing maintenance and enhancements on the RA Qlikview application to ensure accurate real-time reporting of RA KPIs

Supports and enables delivery of Systems and Processes for the SAGA Regulatory Affairs Department

Participates in processes to share information and leverage initiatives across the department where appropriate

Assist with the conduct and complete administration related to the Management of these processes for all products

Support in gathering RA data and ensuring that systems and processes are in place for high-quality data collation and statistical analysis of all RA functions across the SAGA RA environment

Assist with data analytics and provide insights that will drive improvement in both efficiencies and productivity within the department

Support the RA Compliance Officer for the review and approval of all artwork components to ensure compliance to the relevant Acts, regulations, and guidelines and the maintenance of the electronic artwork processes on designated servers

Assist in the objective of RA transformation aligned to business strategy

Supports and encourages knowledge sharing between and or across Regulatory CDT and LCM (SA/ India/ SSA/QCIL), QA, Portfolio, Medical, Project Management, Commercial, BD, IPD, IT 

Constructs and maintains RA Monthly reports from RA Tracking documents using RA electronic systems and processes

Supports the eCTD systems across the RA SAGA region and ensures streamlined central dossiers are submitted across the SAGA region through collaboration with RA CDT and LCM India

Supports the SAGA Regulatory Affairs Director and Regulatory Affairs Department Management team to ensure that Our Client''s values and leadership standards are communicated and understood at all levels within the team

Builds trust among team members by setting a highly visible example in terms of professional excellence and commitment 

Participates and supports the establishment of a team culture that values, recognizes, and generates high performance, supports innovation, and challenges the status quo

Ensures all required SOP’s are in place and maintained on an ongoing basis according to current Acts and internal requirements

Ensure ongoing maintenance and clean-up of document repository (Sharepoint)

Manages the self-inspection program for the department (SA specific)

Supports RA Intelligence SPOC with required reporting as per global SOP, as needed

Supports RA new employee induction training as per Client Induction training program

Supports eCTD coordinator with training on e-systems (Documentum / Extedo), as needed, and assists with the development and maintenance of e-systems workflows

Identifies and develops key relationships within the Our Client SAGA Regulatory CDT and LCM (SA/ India/ SSA / QCIL / CGA), QA, Portfolio, Medical, Project Management, Commercial, BD, IPD, IT

Supports RA Management team to optimise critical relationships with the Health Authorities and Local Technical Representatives (LTRs) throughout SAGA, in order to ensure improved submission timelines, evaluations, and approvals

Communicates company vision and service culture

Provides input and feedback around how the function can service the business optimally

Engages communicates, and collaborates with various internal business units (e.g. Medical, PMO, IPD, QA, Marketing, IT, and BD)

Minimum Requirements

BPharm or BSc. Chemistry or higher post-graduate scientific degree

AA

Cape Town or Johannesburg based

Minimum 2 years of experience in the regulatory function covering all areas

Attention to detail

Resilience

Collaborative approach

Time-management

Good communication skills

Team player

IT skills an advantage

Proficient knowledge of the Medicines and Related Substances Act No. 101 of 1965 and related SAHPRA regulations/guidelines, GMP/GLP/GCP, EMA

Proficient knowledge of the Pharmacy Act No. 53 of 1974, regulations thereto, the guidelines on Good Pharmacy Practice, and Code of Conduct of a pharmacist

Kindly note that by submitting your application for this career opportunity you agree that Guardian Recruiting may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business.

Please note that only shortlisted candidates will be contacted.

Should you not have heard back within a two-week period, please assume that your application was unsuccessful. All job postings are in accordance with our Client''s BEE requirements.

NB! This job is now closed. You can apply for other jobs by uploading your CV.