Description de l'offre
This Regulatory Labeling department, within Regulatory Affairs Function at Roche, leads and supports product teams on the overall development, optimization and implementation of regulatory labeling strategies and activities for the entire product life-cycle. The Regulatory Labeling department is responsible for developing and maintaining company Core Data Sheet (CDS) for medicinal products, and for guiding and supporting the implementation of CDS at country level. As a Global Labeling Strategist (Regulatory Labelling Manager), you will:
· Drive and optimize the strategy for the creation and maintenance of Core Data Sheet (CDS). Provide guidance and expertise to product teams on CDS supporting documents
· Author and maintain CDS, as well as manage the CDS processes in collaboration with regulatory product responsible and product team.
· Guide and support the implementation of CDS into the Local Product Labels and manage local label deviations.
· Lead or contribute to company response to Health Authority requests pertaining to product labeling.
· Lead or contribute to establishment or improvement of working processes and standards
Who we are
At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Packaging & Labelling
· 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.
Who you are
To be successful in this role, you will have/be:
· an minimum a University degree (e.g. Natural Sciences).
· sound experience/expertise in regulatory affairs (preferably strategic labelling). Knowledge in market access is a plus.
· proven ability to lead cross-functional matrix teams with strong influencing skills.
· strong interpersonal & communication skills, fluency in written and spoken English is a must.