The International Product Partner is responsible for leading the development and implementation of the International regulatory strategy for assigned products in Asia Pacific, Eastern Europe Middle East & Africa and Latin America. The International Product Partner is the relevant representative to global teams and affiliates for assigned products, ensuring the requirements of International countries are considered in development and registration plans.
This job is within the Emerging and Regional Affiliates Support Team, who are currently based in Basel and seeking to expand to additional Roche Headquarter sites.
Key activities/responsibilities include:
· Partner to key stakeholders including the Global Regulatory Leader and affiliates, providing advice and guidance on regulatory requirements, procedures and issues
· Ensuring clinical development requirements in International countries are integrated into the global development plan
· Coordinating core dossier dispatch for clinical trial applications (CTAs)
· Preparation and maintenance of the International Filing Plan for New License Applications, New Indications and Line Extensions
· Supporting Health Authority Meetings and responding to Health Authority Questions, providing authoring support as needed
· An ambassador for International regulatory, bringing the voice of the affiliates to the global teams
Who we are
Our UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
Core competencies and skills:
· Teamwork: work effectively to share responsibility as a team member
· Strategic and Innovative Thinking: apply regulatory and scientific knowledge to determine solutions and solve complex problems. Develop clear, effective and creative regulatory strategies to support goals
· Communication and Negotiation Skills: influence individuals or groups on more than one level who may have different interests or goals to reach consensus and achieve team objectives
· Technical Competence: possess working knowledge of drug development and regulatory environment in pertinent therapeutic area or product class. Understand current and historical regulatory environment and its impact on assigned products
Education and experience:
· University Degree, preferably in a scientific discipline
· Proven experience in International Drug Regulatory Affairs
· Knowledge and experience of global regulatory processes
· Basic working knowledge of core processes in drug development, manufacturing and marketing
· Fluency in written and spoken English
In return we offer a competitive salary plus the excellent benefits you would expect from a bluechip organisation, including a genuine interest in your development.
Roche is an equal opportunity employer.
Closing date for applications is Sunday 30th September 2018.
Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs
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La société présente depuis 2004 deux sections parallèles, le secteur pharmaceutique et le secteur diagnostic. Numéro un mondial dans les médicaments contre le cancer ainsi qu'en virologie, le groupe dirigé par le Dr Severin Schwan se focalise essentiellement dans la « médecine individualisée ».
La société est présente commercialement dans 150 pays. Son siège se situe à Bâle en Suisse. Son chiffre d'affaires s'est élevé en 2016 à 50,576 milliards de francs suisses. La société a dépensé 9,915 milliards de francs suisses en recherche et développement. En 2016, l'entreprise compte 94 000 salariés environ