Regulatory Affairs Specialist

3 weeks ago


مصر, Egypt Sanofi Full time

JOB PURPOSE:

- Manage review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines.

KEY RESPONSIBILITIES AND DUTIES:

- Manage review and submission of all maintenance activities (renewal & variations) based on company plans and the authority guidelines.
- Timely implementation of all plans/projects with strict follow up with both internal & external stakeholders for timely achievement of the plans/projects.
- Maintain the products labelling up to date, implementing global and local labelling decisions, through labelling review and approval with respect to internal KPIs.
- Updating internal Sanofi systems regularly and on time following internal KPIs.
- Revision and approval of promotional materials and any updated packaging materials on artwork system.
- Following and complying with all defined internal policies and procedures of working.
- Following strictly all the Authority Regulations, decisions & decrees.
- Carry out all communication and follow up required with local affiliate, region and corporate as appropriate.
- Work in collaboration with internal and external stakeholders to manage issues that might lead to supply impact.
- Familiar with all regulations to support day to day activities.
- Respect quality and compliance aspects.

JOB-HOLDER’s ENTRY REQUIREMENTS_:_

**Education**:

- Pharmacist, Physician, Veterinarian

Related Experience:

- 1-3 years of regulatory affairs experience, preferably in multinational organization

Special Knowledge/Skills:

- High level of communication skills and ability to influence other.
- Organization skills and high accuracy in documentation
- High sense of urgency
- Priority setting and management
- Knowledge of new decrees & guidelines
- Multitasker
- Promptness in respond to authorities’ requirements and prompt in deliverables
- Analytical skills
- Ability to alert hierarchy in case of specific situation impacting his/her work environment
- Problem solving skills
- An understanding and appreciation of relevant legal, scientific and manufacturing area

PTW Behaviors:

- Stretch to go beyond the level we have operated at up until now.
- Take action instead of waiting to be told what to do.
- Act in the interest of our patients & customers.
- Put the interests of the organization ahead of my own or those of our team.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.



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