Global Regulatory Team Leader Oncology and Transplant
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København Ø
Global Regulatory Team Leader Oncology and Transplant
About the Opportunity
Join Sanofi General Medicines Global Regulatory Team as Global Regulatory Team Leader (GRTL). In this role, you will act as the global regulatory lead responsible for developing/facilitating innovative product regulatory strategies and presenting to the appropriate governances as applicable. Additionally, you will be responsible for acting as the global regulatory lead responsible for new development opportunities and executing the maintenance activities for their assigned products for oncology and transplant in General Medicines and Global Health portfolio.
Possible location: worldwide
About the Business Unit – General Medicines
Our General Medicines business includes various areas that are of great importance globally and in our region in terms of the growing number of patients and the wide range of products sold.
In addition to the development and introduction of innovative, new drugs, Sanofi's strength is the wide range of well-established, well-known, and trusted medicines, some of which are still answer unique medical needs. Our broad portfolio provides therapeutic solutions in primary care, cardiology, nephrology, neurology, orthopedics, traumatology, internal medicine, gynecology and many more areas.
The primary responsibility of the General Medicines team is to ensure safe and high-quality drug provision to patients treated in these therapeutic areas.
About growing with us
In this role you will…
- Lead a portfolio of mainly Core asset marketed products for assigned Therapeutic Area (TA) in mainly in US, Europe and key worldwide markets by actively contributing to the development and implementation of innovative regulatory strategies and timelines
- Interact with a cross-functional team in the collection including Global Health program and business, review and assembling of the scientific, clinical, manufacturing and administrative section documents for global submissions to regulatory authorities. Lead and/or represent GRA on Global Regulatory Teams and/or GBU project teams
- Ensure the appropriate peer review of key regulatory documents and submissions across programs in the portfolio. Proactively identifies and communicates to higher management all potential risks and options for issue resolution (e.g. maintenance issues, submissions, etc.)
- Research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
- Recommends improvements to operating policies/processes. Ensure compliance with all internal and external requirements and procedures
- Maintain professional working relationships with colleagues, fostering collaboration and idea sharing
About you
Qualifications/ Education & work experience
- Bachelor’s degree in a scientific discipline, Master or PharmD or PhD represent an asset
- 5+ years of experience in Regulatory Affairs or relevant industry experience
- Knowledge and experience with Manufacturing, QA/QC and/or clinical development
- Demonstrated ability to prioritize multiple projects
- Strong multicultural awareness is a must
- Excellent communication and organizational skills as well as attention to detail
- Ability to work in a matrix team environment with strong interpersonal skills (collaborative, tactful and diplomatic)
- Motivated, self-starter, and ability to work independently with minimal supervision
- Sense of urgency and perseverance to achieve results and deadlines
- IT skills: Proficient in MS: Word, Excel, PowerPoint and Project
- Oral and written fluency in English
Inspire your Journey.
What Sanofi can offer you
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
- An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management)
- An individual and well-structured introduction and training when you onboard
- You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully
- As a globally successful and constantly growing company, Sanofi provides international career paths as well
Pursue Progress. Discover Extraordinary.
If you feel you have the required experience please apply NOW, alternatively contact [email protected] directly for more details.
https://www.Sanofi.com/en/careers/
Own your future. Make your move!
For GDPR reason we are not accepting any application via email. Only applications received via Sanofi sites will be considered. Applications received outside our platforms won't be reviewed
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.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København Ø.
Jobbet er oprettet på vores service den 25.2.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Afdelingsleder
- København Ø
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