Job title: International Region Product Lead - Regulatory Affairs / General Medicine GBU
Grade: L3-1
Hiring Manager: May Li Woon
Location: Remote , SP
Job type: Permanent, Full time.
About the job
Our Team
The International Region Product Lead will be accountable for the management of assigned projects in International Region, ensuring implementation of regulatory strategy, aligned with the Glocal and Play to Win models, being responsible for New Drug Applications (NDA), Territory Extensions, Line and Indications Extensions and cooperating for the LCM activities with other GRA functions, as per defined roles and responsibilities. The International Region Product Lead will represent GRA International countries needs and liaison with global teams, influencing decisions and seeking for win-win situations as focal point between countries and global teams.
Main responsibilities
Manage regulatory activities for the assigned portfolio of the GBU (oversight on the key LCM activities with relevant stakeholders)
Set up New Product Plan (NPP) roadmap for the product of the GBU
Ensure development of robust regulatory strategies and tactical plan for new registrations, territory extension and line extensions, and ensure its implementation as per NPP
Keep a good working relationship with internal and external stakeholders, be a business partner for the International GBU
Ensure representation of International regulatory position in GRTeams, respecting blueprint model and assuring correct understanding of International regulatory environment and needs
Assess feasibility of regulatory strategy aligned with International commercial franchise heads
In collaboration with GRTL and business archetype, develop GSS/filing plan
Manage with other functions the preparation, dispatch & follow-up until the approval (including MoH questions) of the assigned submissions in a timely manner
Manage with affiliate and regional/global teams the preparation of the dossiers (briefing package, slide kit) for pre-submission meetings
Ensure relevant regulatory database are updated, as applicable for your function
Coordinate the assessment of the implications of Product Alerts and Product Discontinuations in the region and ensure all required actions are taken within a timely manner
Work in collaboration with GRTLs for a development a strategic labeling as needed
Actively support Business Development assessments, as applicable
Ensure peer review of key regulatory documents across programs in the portfolio
Keep GRT updated on regulatory trends in International Region
Ensure compliance with requirements and procedures and suggest improvement to operating policies/processes, as appropriate
Ensure overall implementation of team goals and support harmonization of ways of working
Involvement in special regulatory related projects as lead or workgroup members as needed
Managers
• Promote the culture of Ethics and Business Integrity in your team by serving as a role model by ensuring appropriate knowledge and adherence to the principles of ethics and integrity, Sanofi policies and codes of conduct that regulate the pharmaceutical market.
• Comply with and promote Sanofi Health, Safety and Environment (HSE) policies in relation to the team it manages, which includes the Road Safety Program (Road Safety) with the purpose of preventing accidents, avoiding health risks, promoting the well-being of employees and reducing environmental impacts resulting from the execution of their work activities.
• Support Sanofi Diversity, Equity and Inclusion strategy and initiatives to ensure all employees and partners are treated with respect and receive equal opportunities.
About you
Minimum of 5 years’ experience in Pharmaceutical development, Regulatory Affairs, Clinical, Pharmacovigilance or Quality Assurance
Experience working within an international company with a complex organizational environment
Project management experience in the pharmaceutical industry or in a regulatory environment. Recognized expert in managing matrix teams
Understanding of the pharmaceutical industry, drug development environment, maintenance processes and objectives
Comprehensive knowledge and operational expertise of the international regulation
Ability to evaluate the impact of regulations on drug development environment
Ability to produce written/oral regulatory or scientific communications with clarity, accuracy and rigor
Ability to manage stakeholders, with transversal leadership and decision & risk taking attitude
Ability to communicate effectively and efficiently with other functional departments in the business and with Health Authorities
Ability to act as change agent, fostering simplification and efficiency mindset
Good organizational skills and ability to manage 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 and in a matrix organization
Core competencies /skills:
Act for Change / Cooperate Transversally / Strive for Results / Commitment to Customer / Think Strategically / Make Decisions / Teamwork ability: good interpersonal & communication skills / Ability to work in a matrix organization / Business and customer orientation / Networking and influencing skills
Language:
Fluent in English
Note: Remote working. Applicant from countries other than what is listed will be considered.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t 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, let’s 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.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Attention to the Phrases Below
*Always aimed at the safety and well-being of our employees, proof of COVID-19 vaccination is an essential item for all employees, being present on the list of admission documents.
#LI-LATAM
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.
DATE POSTED
04/28/2023
CONTRACT TYPE
Full time
JOB ID
R2688286
LOCATION
Petaling Jaya;Casablanca;Ciudad de México;Taguig;