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  • Regulatory Affairs Associate Saudi Arabia
  • Novartis Pharma AG in Saudi Arabia, , Saudi Arabia
  • jobs
  • 1 week ago

jobs description

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About the Role

Major Accountabilities:

Health Authorities Interaction & Regulatory Intelligence:
- Build and ensure to have good level of relationship with the Health Authorities.
- Maintain an oversight on all RA guidelines/requirements at national level.
- Prepare all the required documents/dossiers for the major activities (new registrations/ line extensions/ new indications/ HA requests & commitments) and/or relevant maintenance activities (Variations /Renewals /SLCs /RMPs/ PSURs) to achieve a favorable out-come.
- Circulate all communications/queries received from HAs as needed to the manager and relevant stakeholders at global & local level.
Regulatory dossiers & Product lifecycle maintenance:
- Prepare all the required documents for NDA/ LCM activities (new indication/ variations/ renewals/ SLCs/ PSURs /RMPs/safety communications etc.) by ensuring their readiness as per strategy so submission can take place in a timely manner.
Product... information & Labelling activities:
- Prepare and track submission & approval of product information updates and manage this activity until having successful and smooth implementation.
- Create artworks in line with the approved information by the HAs in the artwork management system (e.g., OneArt). Also, ensure informing relevant stakeholders timely at local & global level about effective (BSS/CDS/NSS/PPMS/etc.).
Operational Excellence & Regulatory Compliance:
- Ensure adherence to local & global SOPs/WPs during daily regulatory activities.
- Monitor global compliance reports (e.g., SALTO/ CCEX/ DRA QUEST, etc.) and work proactively on having continues improvement in terms of KPIs results.
- Ensure global surveys/trackers are up to date in accordance with effective local regulations.
- Prioritize submissions/ approvals and implementations of key regulatory activities (e.g., new products/ new indications/ production transfers/ local MAT / Divestment projects, etc.) as per the plan.
- Support HA inspections, global GMP & PV audits, self-assessment, deviations, quality events and respond adequately to all requests about regulatory area.
Collaboration:
- Coordinate with Global/Regional Brand Regulatory Managers (e.g., GPRM, GPRD etc.) & with other relevant functions (RA CMC, RA Ops, RA LCM, etc.) to ensure having the registration documentation/requirements on time as per plan.
- Collaborate and align as needed with other local cross functions (e.g., patient access, commercial, medical, legal, supply chain, quality etc.) about: product details requests/ regulatory submission plans & implementation/ external alignments/ promotional & non-promotional material Review/ Safety communications, etc.).
- Communicate of any changes (New Regulations/SOPs/WPs/etc.) that may impact Novartis to all relevant Stakeholders.
Information and record management
- Ensure to maintain Regulatory Information Management systems/databases and all relevant RA tools (e.g., Dragon/REDI-GO/PULSE. etc.) with the most updated data and approved information from local HA.
- Archive properly and timely regulatory documents in relevant record locations as per their classification in Novartis.
Training
- Complete all assigned trainings within the provided timeframe.
Team
- Collaborate & support other team members to succeed in achieving team’s goals/objectives.

Key Performance Indicators

The timely registration of new drug products, line extensions, new indications. Accurate & timely maintenance of products life cycle management. Accurate & timely update for Novartis products labels, leaflets, and safety information. Timely & accurate development & implementation of new artworks (leaflets/ Folding boxes, etc.) Compliance of the promotional materials with the registered/approved PI. High regulatory compliance percentage for SALTO report & DRAGON & all other relevant databases. Keep the relation with all related parties (inside & outside NVS) at the top level of respect, confidence & reliability.

Education:

Bachelor’s Degree in pharmacy or any equivalent degree.
Experience :
1-2 years Regulatory experience.

Why Novartis:

Join our Novartis Network:

Saudi Arabia REQ-10004881

Regulatory Affairs Associate

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