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.