Regulatory Transversal Project Lead for NBM ESA & GHU will report to Country Regulatory Head Morocco Tunisia Libya
Overall Responsibilities
NBM ESA
- Responsible for Transversal activities that support Regulatory Africa Zone Organization.
- Point of contact for GRA performance, quality, operations, and transversal activities to assure that Distributors are well trained and equipped to perform their activities and deliver commitments to Business Units and external stakeholders.
- Responsible to interact with the distributor to collect any new regulatory publications, requirements and ensure data base update.
- Responsible to monitor with the distributor the timely submission and approval of the dossiers.
- Main interface with the RA team of the distributor between the distributor and Global GHU team
- Responsible to monitor with the distributor the timely submission and approval of the dossiers.
- Responsible for transversal activities that support Regulatory GHU Zone Organization.
- Responsible to interact with all the appropriate stakeholders to ensure compliance of the GHU products and timely update of the Sanofi data base according to regulatory requirements and Sanofi policies.
- Demonstrated ability to independently lead teams and implement regulatory strategies.
- Excellent understanding of the pharmaceutical industry, drug development environment, and company processes and objectives.
- Expert knowledge of AFRICA pharmaceutical regulations and requirements, Health related regulations (i.e. ICH, FDA, EU, WHO, ANSM, MHRA, Emergent Markets, etc.).
- Ability to evaluate the impact of the regulations on drug development and the regulatory maintenance of Marketing Authorizations.
- Comprehensive knowledge and operational expertise of the international regulations.
- Ability to communicate effectively and efficiently with other functional departments in the business.
- 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 quickly gain required therapeutic / product knowledge.
- Ability to work with multifunctional and multicultural teams.
- Fluent Business Language
- Awareness and adherence to company internal SOPs & compliance standards.
- Promptness in respond to authoritys requirements and prompt in deliverables.
- Analytical skills.
- Problem solving skills.
- An understanding and appreciation of relevant legal, scientific and manufacturing area.
Experiences
- Education: Physician, Pharmacist, Chemist, Biologist.
- Related Experience: Minimum of 5 years experiences in pharmaceutical development, Regulatory Affairs, Clinical, Pharmacovigilance or Quality Assurance.
- Project management experience in the pharmaceutical industry or in a regulatory environment. Recognized expert in managing matrix teams.
- Push to go beyond the level we have operated until now : constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what wont: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment
- Put the interest of the organization ahead of own of those of his her team : consider both short and long term impact of decisions ; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level
- Act in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings an external perspective into decisions.
- Take action and dont wait to be told what to do: take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others advice to make bold and impactful decisions which move us forward.
Better is out there. Better medications, better outcomes, better science. But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, lets be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
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Sanofi IS AN EQUAL OPPORTUNITY EMPLOYER If you are interested in applying for this vacancy and you are confident that you meet the criteria set out in the advertisement kindly click on the link below
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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.
