COE regulatory Manager - Sanofi

• JOB PURPOSE

  The AMEE RA COE Country Manager will report to ME Arabic Speaking Countries COE

  Cluster RA Head and will lead a team of AMEE RA COE Country Associates.

  To achieve success it is critical that the The AMEE RA COE Country Manager:

  • will lead a group of COE Regulatory Associates in a country.
  • will be responsible for the management of the post-approval changes and regulatory compliance of a portfolio of marketed products in one or several countries.

  KEY RESULTS / ACCOUNTABILITIES

  1. Startegic management of the regulatory compliance of the marketed product portfolio

  • Manage and monitor the regulatory compliance of the Sanofi marketed product portfolio in Egypt & Sudan
  • According to the country regulatory requirements and planning, assess, coordinate and contribute to the preparation of ready- to- submit regulatory dossiers for the below :

  -Labeling, CMC, administrative and renewal /annual report

  -Site registration, GMPc renewals

  -Packaging and Artworking

  -Tender

  -Any type of response documents to the Health Authorities questions by interacting with the relevant stakeholders (BU region regulatory, GRA, RSO local medical, local Pharmacovigilance department etc.) and monitoring of dossiers dispatch up to submission.

  • Ensure regulatory compliance with products overall strategies and Health authorities country requirements evolution
  • Ensure tender preparation if regulatory dossiers is needed
  • Be compliant with all internal and external requirements, procedures and tools,
  • Foster an environment/culture of learning and sharing of best practice within the team

  2. Develop and maintain a good working relationship with internal and external stakeholders

  • be a business partner for the Country regulatory teams 
  • be a business partner for Global CMC&Devices, Global Labeling, RSOs
  • represent the regulatory position to senior management as needed

  1.    3. Ensure the overall implementation of goals and strategies of the group

  • Ensure the harmonization of ways of working as part of the leadership team of the COE Region.
  • Implement in timely manner , country plannings for dispatch and ensure alignment between COE activities and Regional BU/Country activities via “mutually agreed roles and responsibility sharing docs” and dispatch KPIs

  2.    4. Serve as the line manager for the staff of the COE country associates

  • Serve as the line manager for the staff of the COE country associates.
  • Serve as a coach and mentor to the staff and establish objectives and development goals for the team

  5. People Leadership

  • Performance manages the team through setting and reviewing priorities.  Provides appropriate and timely feedback about performance and coaches team members to help them achieve their goals
  • Supports the professional and career development of the team by identifying the skills and competencies that employees need for their current and prospective roles and provide opportunities to learn and practice new skills
  • Leads the building of a motivated and engaged team through the use of formal and informal recognition, regular communications and the encouragement of cooperation between individuals and teams

  6. Maintain Compliance 

  • Abide by the requirements of the internal 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 

  7. 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

  8. 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
  • Assist in the investigation of accidents with the objective of introducing measures to prevent recurrence
  • Thoroughly read all safety documentation issues by the Company and comply with its requirements. Escalate any doubts or uncertainties to their supervisor and / or manager.

  SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

  Education Level:

  o   Physician, Pharmacist, Veterinarian or Scientific background with preferably Regulatory Affairs Master Degree

  Experience:

  o   More than 5 years experiences in Regulatory Affairs

  o   Team management experience

  Skills:

  o   Demonstrated ability to independently lead regulatory teams and implement regulatory strategies

  o   Project management experience in the pharmaceutical industry or recognized expert in managing matrix teams .

  o   Technical expert in using digital tools and applications, microsoft office tools

  o   Knowledge in regulatory requirements and  Good Manufacturing practices of the Countries in his/her scope

  COMPETENCY REQUIREMENTS            

  • Excellent understanding of the pharmaceutical industry, drug development environment, Research & Development and maintenance processes and objectives,
  • Expert knowledge of pharmaceutical international regulations and requirements, Health related regulations of the region/cluster under her/his responsibilities
  • Strategy thinking, result oriented, decision making
  • Leadership skills
  • Develop People / Other
  • Act for Change
  • Specify level of competency (Advanced)
  • Cooperate Transversally
  • Specify level of competency (Advanced)
  • Ability to evaluate the impact of regulations on drug development environment and maintenance, lead discussions of the requirements and impacts with teams,
  • Comprehensive knowledge and operational expertise of the international regulation,
  • Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor,
  • Strong interpersonal skills to lead and  motivate the team and liaise effectively with internal and external contacts,
  • Ability to communicate and interact effectively and efficiently with other functional departments in the business and with Health Authorities,
  • Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines.  Ability to foresee and respond to potential problems and opportunities,
  • Ability to act as a Business Partner,
  • Ability to work with multi functional and multicultural teams and in a matrix organization,
  • Language requirements: Fluent in written and spoken English and Arabic as native language 

  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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