Ra Associate

**Summary**:

- Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

**About the Role**:

- Achieve the best product registration with commercially attractive labelling in accordance with registration plan -Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance -Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.) -Foster and maintain good relations with internal and external stakeholders -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
- Support submissions and approvals for of new products, line extensions, new indications, renewals, clinical trials, safety label changes and quality/CMC variations.
- 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.)

**Key performance indicators**:

- Project & stakeholder feedback -Product license update in terms of CMC in agreed timeline -Adherence to Novartis policy and guidelines
- 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.

**Minimum Requirements**:
B.Pharm or life sciences degree or equivalent

Computer literate MS office, excel and PowerPoint
**Work Experience**:

- Functional Breadth.
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.
- ** Experiences **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 Skill.
- Clinical Trials.
- Collaboration.
- Detail Oriented.
- Lifesciences.
- Project Planning.
- Regulatory Compliance.

**Languages**:

- English.

Division

Development

Business Unit

Innovative Medicines

Location

South Africa

Site

Midrand

Company / Legal Entity

ZA01 (FCRS = DEL) South Africa

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

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