Regulatory Affairs Manager

Job title: Regulatory Affairs Manager

• Location: Riyadh, Saudi Arabia
• Job type: Full Time

About the job

The Country Regulatory Manager will be responsible for leading a subset of the Business Unit portfolio of development and marketed products in one or several therapeutic area(s). In this capacity, he will be accountable to the Country Regulatory Affairs Head for the overall regulatory strategy for products in assigned portfolio.

To achieve success, it’s critical that the Regulatory Manager work with:

• Registration KPIs
• Share KPIs
• Compliance
• HA Contact Reports

Main Responsibilities:

• Working closely with Pharmacovigilance & Medical to ensure timely submissions & follow up on products alerts & periodic reports
• Carrying the planned Activities and reflecting the approvals on the internal systems
  Work closely with supply chain to ensure labelling implementation
• Plan for preparation / review and submission of all the maintenance activities, new applications based on company plans and the agency guidelines, this includes working with COE.
• Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
• Maintain the products labelling up to date, implementing global and local labelling decisions , through labelling preparation, review and approval
• Updating the internal Sanofi Systems regularly
• Carrying the planned life cycle management (LCM) activities and reflecting the approvals on the internal systems
• Revision and approval of promotional materials.
• Working with internal stakeholders in preparation, submission and follow up of pricing, internally and externally, as per local processes.
• Following and complying with all the defined internal policies and procedures of working.
• Following strictly all the Authority Regulations, decisions & decrees.
• Carry out all the required communication and follow up required with local affiliate, zone, region & corporate as appropriate.
• Working with SC & Quality to report shortage alert to HA.
• Grant HA approval to import certain quantity of product to avoid possible shortage if needed.
• Working with brand team to set product strategies.
  Maintain Compliance
• Abide by the requirements of the internal and local 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 (Sanofi Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.
• Escalates any decisions, or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role.
  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 HSE rules and procedures to ensure a safe, healthy, and pollution free work environment.
• Follow HSE guidelines and take all necessary measures applicable to effectively implement the ‘HSE action plan (PASS)’ in the work area and the activities.
• 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, no smoking inside the office premises etc.
• Attend HSE training and implement the learnings.
• Participate in the HSE related activities, campaigns, events etc. and adopt the learning in day to day work activities
• Report all the accident/ incident (if any) to the Line Manager and the HSE Manager, and help to investigate further.
• Thoroughly read all HSE instructions, procedures, policies issued by the Company, and comply with its requirements. Escalate any doubts or uncertainties to the Line Manager.

About you

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

Qualifications:

University degree, preferably in life science preferred MD, PhD, PharmD, Advanced degree preferred

Experience & knowledge:

o 5+ years experience in Regulatory Affairs

o Experience in working with Saudi FDA

Languages:

o English – full professional proficiency

o Arabic