RA Associate

Job Description

JOB PURPOSE

• To support in registration/approval of new products, line extensions, new indications, clinical trials, variations, support regulatory maintenance activities of the registered base portfolio, ensure optimization and regulatory compliance. Support regulatory maintenance activities and ensure optimization and compliance for registered as well as managing all regulatory matters in all spheres of activity [Registration, Production/NTO, Marketing supply chain (SC), Patient safety (PS), Quality Assurance (QA), etc.] and to provide internal and external scientific and marketing advice/expertise. To support submission and communication of PV related reports, QA related matters.
• Support in engagement and collaboration with internal stakeholders as well as establishment and maintenance of strong working relationships with key external stakeholders.
• To support in monitoring and communication of regulatory requirements, intelligence and policy to facilitate strategic planning for product registration, maintenance of registered base portfolio, clinical trials, policy shaping, capability building and harmonization initiatives across ESA.

Major Accountabilities

• Support submissions and approvals of new products, line extensions, new indications, renewals, clinical trials, safety label changes and quality/CMC variations.
• Performance of due diligence of dossier information/registration documents received from global and other appropriate sources.
• Ensure timeous compilation, submission and approval of variation applications.
• Review and submission of all variations/amendments according to the Global and HA Guidelines.
• Support in engagement & collaboration with internal stakeholders as well as establishment and maintenance of strong working relationships with key external stakeholders.
• Support development and maintenance of dashboards and trackers designed to improve regulatory processes within ESA.
• Monitor, identify and escalate emerging policy information and regulatory intelligence.
• Support collection and maintenance of regulatory requirements, monitor internal and external solution trends (CTA Hub, third party etc.).
• Communicate new and emerging regulatory requirements to RA colleagues and relevant line functions via written communication such as newsletters, information e-mails.
• Support and update local/Regional Working Practices or SOPs when required.
• Ensure adherence to Global and local/regional processes.
• Evaluation of changes for impact on product supply. Ensure the relevant stakeholders e.g. Supply Chain Management, QA and Marketing are aware of any impact.
• Maintenance of relevant regulatory databases.
• Maintain all necessary Novartis databases (e.g., DRAGON, REDI-GO, etc.) to ensure regulatory compliance at all times.
• Responding to the requests adequately, satisfactorily and timeously for both internal and external customers.
• Timely, accurate and proactive regulatory related communication of general or project specific items to key stakeholders as appropriate.
• Provide technical and scientific support to Medical, Market Access, Supply Chain, Marketing and QA. Review and approval of marketing promotional materials.
• Ensure prompt submission of post approval commitments, PSUR submissions, RMP submissions, SLC updates and ensure timely responses to HA as required.
• Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary.
• Ensure compliance to global and local KPIs.
• Drive collaboration within RA team and cross functionally.
• Corporate Governance: Performing all daily activities in line with the Novartis policies and Code of Conduct.
• Support Novartis culture journey and role model Novartis V&B.

KEY PERFORMANCE INDICATORS

• Number of achieved standard and stretched submissions and registration/approval milestones/deliverables related to new registration, line extensions, new indications, variations, renewals, annual retentions, clinical trials.
• Ensure timely submission and communication of PV related reports (e.g., PSUR, RMP, HA request, safety concerns, etc.) and QA related matters.
• Achievement of Regulatory compliance deliverables as per global/regional/cluster targets within the assigned county/cluster.
• Proactive communication of new and evolving regulatory requirements to relevant stakeholders.
• Timely and accurate tracking of relevant information.
• Strong working relationships with key stakeholders (HAs and other external stakeholders).
• Maintaining minimum of 95% DRAGON compliance in update of new received post distribution changes to normal country folders and brand safety folders
• Keeping and improving strong relations with Health Authority's officials.
• Product Deliveries to the markets according to plans (no stock outs due to out of compliance).
• Providing regulatory guidance on promotional material and support with HA approvals.
• Provide technical and scientific support to Medical, Market Access, Supply Chain, Marketing and QA.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

MINIMUM REQUIREMENTS

Education (minimum/desirable):

• B. Pharm or life sciences degree or equivalent.
• Computer literate MS office, excel and PowerPoint

Experience/Professional requirement:

• Minimum 1-3 years experience in pharmaceutical regulatory affairs environment.
• Knowledge and experience: Knowledge of Regulatory requirements for Medicines in the East and/or Southern Africa countries.
• A good understanding of pharmacology, pharmaceutical and clinical data and the pharmaceutical market.
• Ability to implement and drive execution.
• Skills: Analytical and Interpretive; Detail oriented and organized; Ability to set standards and objectives and monitor progress; Prioritize workload to tight deadlines; Excellent communication; Cross functional ability/Good interpersonal skills; Innovative, problem solving and decision-making ability.
• Behaviours: Attention to details, Pro-active, People-orientated, Organizational awareness.
• Project management.
• Ability to travel and represent the organization.

Languages:

• Fluency in English as a business language. Portuguese/
• French is a plus.

Division

Global Drug Development

Business Unit

REG AFFAIRS GDD

Country

South Africa

Work Location

Gauteng

Company/Legal Entity

Novartis SA (Pty) Ltd.

Alternative Country 1

Ethiopia

Alternative Country 2

Kenya

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

Yes