Regional Manager

24 Jul 2018
06 Feb 2019
Regulatory Affairs
Within the Emerging and Regional Affiliates Support Team, you will be responsible for supporting regulatory activities for all countries within an assigned region (APAC, EEMEA or LATAM).  You will be the primary global contact for local regulatory affairs colleagues, and in collaboration with key functions from the global headquarters will manage the provision of submission documentation.  You support new product registrations and lifecycle maintenance, as per the agreed product strategy and are a strong partner for global and local colleagues.

Specific responsibilities include:
  • Provide expert knowledge on regulatory requirements and environment .
  • Work in close collaboration with the International Product Partner to build regulatory strategies and ensure timely submission of initial marketing authorisations
  • Ensure oversight of affiliate regulatory submissions and approvals in order to support all lifecycle activities for the Roche portfolio, ensuring optimal lifecycle strategy
  • A strong partner to affiliates, finding solutions and challenging the status quo
  • Build a network with global key stakeholders (e.g. Technical Regulatory, Supply Chain, Quality & Regional Commercial) to ensure business priorities are met
  • Liaise with affiliate commercial and medical organisations (e.g. General Managers, Country Managers, Medical Directors) to ensure regulatory contribution to the overall business priorities
  • Lead knowledge sharing and collaboration across the countries and the global organisation
  • Organise and lead meetings within the region to promote cross functional working (e.g. share initiatives, align affiliate regulatory priorities with global)
  • Participate in projects and initiatives outside of the core scope of the Regional Manager responsibilities

Minimum Qualifications and Experience
  • University Degree, preferably in life science discipline.
  • Extensive experience in regulatory affairs
  • Proven successful experience in international regulatory affairs of value
  • Knowledge and experience of global regulatory processes
  • Fluency in written and spoken English

The closing date for applications is Monday 20th August 2018.

Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

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