The Global Regulatory Affairs must register new vaccines as quickly as possible and ensure the maintenance of the approved product licenses throughout the product lifecycle in order to meet the needs of their customers taking into consideration compliance with the local and regional regulatory guidelines.
As Regulatory Affairs Registration Manager Senior, you're a the Regional Expert who will provide support to the team for Emerging Markets Central (MENA, CIS and Russia) to:
• Act as the Emerging Market Central regulatory Vx voice through the organization
• Act as a strategic partner with Central teams & LOCs
o Act as a regulatory champion Emerging Markets - green table countries
o Provide guidance & advice, regulatory expertise for the region including impact assessment & recommendation/position
o Escalation of issues & risks to the central organization
o Lead regulatory activities in issue solving when multiple products or 1 product multiple countries
o Responsible for ensuring proper consideration of local and regional legislation and regulatory expectations
• Contribute actively in the definition of the Regulatory Strategy (Development & LCM)
o Provide input, be responsible for the regional aspects
o Facilitate the decision making by providing relevant information proactively
o Advocate RPT decision
• Provide support & direction on regulatory activities to Vx portfolio (LCM & development) aligned with commercial priorities
o Take appropriate action to ensure harmonization of WoWs
o Lead regulatory activities when multiple products
o Provide proactively update on on-going activities for our key stakeholders
o Define & communicate priorities aligned with green table and Vx objectives
• Contribute actively to the HAs meeting / inspection
o Lead portfolio meeting as needed
o Review briefing package, Attend the meetings, Alignment across Vaccines
o Train Health Authorities
o Act as SPOC for cross products inspection
• Be the bridge between Vx organization and Rx/LOC fo regulatory matters for the region
• Lead or participate actively to internal working groups by providing regional expertise and representing region or group or GRA Vx
• Ensure the maintenance of transversal process owned by the Region such as site registration, Normative Documents and eCTD
Education / Training:
A first degree in a relevant science subject. Ideally in life sciences (eg, biology, chemistry, pharmacy etc). Specialization in the area of pharmaceutical/biology/vaccinology would be beneficial.
Regulatory experience is a MUST.
At least 10 years regulatory experience in the pharmaceutical industry ideally in Vaccines or Biological fields covering international markets or first hand experience in the region of the Job Holder's (JH) responsibility.
Experience of working with remote teams, of managing by influence and working in a highly matrixed environment. Ability to develop relationships based upon trust and mutual respect.
Experience of project management and leading projects to successful conclusion is essential (ideally in development/registration projects)
Self-motivated, proactive with the ability to work autonomously, to develop credibility with colleagues within and outside the company.
Recognized excellent presentation/communication skills, both oral and written, fluent in English. Additional language skills (particularly related to the region(s)/country(s) of the JHs responsibility would be beneficial.
Agile and ability to inculcate IPTc (Innovation, Performance and Trust) values.