Regulatory Affairs Manager
6 hours ago
**Summary**:
The RA Manager will be responsible to develop & execute submission & approval strategy for all regulatory activities & to ensure ethical conduct and compliance with applicable national and international laws, codes and regulations.
**About the Role**:
- Manage, supervise and coach DRA associates to achieve the business objectives in term of new Launches and life cycle maintenance activities.
- Provide adequate training and guidance to all junior regulatory associates as relevant
- Maintenance of registered products - With no supervision, maintain registration of currently approved products
- Product Information and Consumer Information - With no supervision, maintain product information and consumer information ensuring the correct use of the approved versions of these documents
- Relationships within and outside the company - Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with health authority and industry bodies, such as the SFDA.
- Provide valuable regulatory advice as necessary.
- Assist Medical Information and Quality Assurance with product detail requests wherever feasible.
- Ensure the compliance of Regulatory database system’s content & data maintenance activities (Dragon, Regulatory Intelligence Database...etc.).
- Create, maintain, Review & approve products artworks & leaflets & set-up the proper plan for implementation.
- Create, review & maintain BSS for all promoted products.
- Review and approve Printed Packaging Material Sheet (PPMS) received via AQWA.
- Monitor, Communicate & distribute All SFDA new regulations & guidelines among all the concerned departments in the CPO, Regional RA team and Global RA team.
- Review, Analyze and implement All SFDA new regulations & guidelines.
- Review & approve promotional materials & activities in compliance with applicable company & country regulations & policies.
**Key Per**f**or**m**ance I**n**d**i**cat**o**rs**
- The timely registration of new drug products.
- 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 for leaflets & folding boxes.
- High regulatory compliance percentage for SALTO reports & DRAGON & all other relevant databases.
- Keep the relation with all related parties (inside & outside NVS) at the top level of respect, confidence & reliability.
- Performance management and coaching of the relevant DRA team.
- High regulatory compliance percentage for SALTO reports & DRAGON.
- Compliance of the promotional materials with the registered/approved PI.
Ideal Background
Education:
- Bachelor Degree in pharmacy or any equivalent degree.
- Master degree is preferred.
**Experience**:
- 5-7 Years in Regulatory Field.
- Deep understanding of SFDA and GCC regulatory system and rules.
- Strong Management skills.
- Excellent organization skills and ability to work on a number of projects with tight timelines is required.
- Strong Negotiation & Analytical skills
- Strong Interpersonal & Communication skills
- Excellent Computer skills (Word, Excel & PowerPoint).
- Fluent in Spoken & Written English.
Division
Development
Business Unit
Innovative Medicines
Location
Saudi Arabia
Site
Riyadh
Company / Legal Entity
SAP0 (FCRS = CH024) Novartis Consulting AG
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.
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