Regulatory Vacancy At Sanofi Egypt
Position Title:
Regulatory Associate
Location: Cairo, Egypt
About the job:
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
JOB PURPOSE:
Responsible to review and submit new application corresponding to company strategy and plan as well as the regulatory authorities’ guidelines for submission.
Responsible to review and submit all maintenance activities (renewal & variations) based on company plans and the regulatory authorities’ guidelines.
KEY RESPONSIBILITIES AND DUTIES:
Manage new applications submission corresponding to company plan as well as the regulatory authorities’ guidelines for submission.
Manage review and submission of all maintenance activities (renewal & variations) based on company plans and the regulatory authorities’ 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.
Managing the review and approval of promotional materials and any updated packaging materials on internal Sanofi systems.
Ensure compliance to all regulatory activities with all applicable laws, regulations, regulatory authorities’ requirements and company internal procedures.
Following strictly all the Authority Regulations, decisions & decrees.
Be Familiar and up to date with all authority regulations and internal Sanofi rules to support day to day activities.
Carry out all communication and follow up required with local affiliate, region and corporate as appropriate to support regular activities.
Interact with representatives at regulatory authority level to support regular activities.
Work in collaboration with internal and external stakeholders to manage issues that might lead to supply impact.
Respect quality and compliance internal Sanofi aspects, work in compliance with Sanofi Quality Documents (QDs).
Support in fulfilling any request from internal stakeholders related to portfolio in scope.
Adhere to internal KPIs and avoid deviations in activities in scope.
Others:
Perform other duties as assigned.
Respect of company’s values, code of ethics and social charter.
Respect of personal data protection charter.
Responsible for applying the HSE related requirements for the company in all related working procedures.
Maintain Compliance
Abide by the requirements of the code of Ethics including but not restricted to maintaining high professional standards of conduct in line with the Company procedure with a duty of care to the reputation of the Company
Ethical Leadership
Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (including the Industry Code of Practice, Sanofi Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.
Environmental and Safety Leadership
To care for his/her own safety and wellbeing and the safety of others, and to co-operate with the company to ensure a safe place of work. Employees are therefore expected to:
Support and conform to Company safety rules and procedures to ensure a safe and healthy working environment
Report any accident, incident or near miss, whether it be of personal injury or property damage
Thoroughly read all safety documentation issues by the Company and comply with its requirements.
Health, Safety and Environment Responsibilities
Comply with company procedures and current regulations on hygiene and safety.
Properly use the work equipment, dangerous substances, and preparations as well as the supplied collective and personal protective equipment according to the instructions received.
Promote and follow the HSE rules and ‘Act responsibly’ to protect yourself and others from an injury and ill health conditions while at the work locations and/or while using road e.g. traffic rules, emergency evacuation procedure, medical surveillance, healthy lifestyle etc.
Engage the HSE department in the related activities (where applicable) and be sure that the work performed follows the local HSE regulations, Corporate HSE Policy and key requirements.
Attend HSE training.
Promptly report to your superior any dangerous conditions of which you become aware
About You
Education: Advanced bachelor’s degree in life sciences, or a related field
Related Experience: minimum of 3 years’ experience in similar position in different types of registrations, 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.
Ability to work with agility and autonomy.
An understanding and appreciation of relevant legal, scientific and manufacturing area
Sanofi Leadership Framework Skills and Behaviours
Skills:
People Leadership:
Leadership of diverse and remote teams
Teambuilding, teamwork, transversal lead
Strategic Thinking:
Business and financial acumen
Analytical skills
Decision making
Challenge status quo with innovation
Relationship and influence:
Communication and consulting skills
Negotiation and influencing skills
Inspires trust through empathy and authenticity.
Coaching & facilitating skills
Change management
Result Orientation:
Strong on execution, is comfortable with ambiguity, and adapts with agility.