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Head, Regulatory Affairs, Americas - 103BR - Seqirus

Cambridge, MA - Massachusetts, United States

Posted: 25-May-2016

Ref#: 12345695663


Are you looking for a rewarding career in a market-leading and innovative company?

Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create what is now the second largest influenza vaccine company in the world.  With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.

Role Overview

The Head Region, US & Americas is a member of the Global Regulatory Affairs (GRA) Leadership Team. This role contributes to the vision and goals for GRA and ensures that the International Regions objectives are aligned with the strategic objectives of GRA and US & Americas Commercial Group.
Provide leadership, strategic direction and managerial oversight to the US, Canada and LATAM based regulatory teams to develop and execute regulatory strategies and plans for the region.
Interface with other function leads (e.g. R&D Leaders : Clinical Development/Medical Affairs/Safety/Technical Development; Commercial Leaders: Americas & Commercial Development and Quality Operations Leaders such as CQA ) to ensure collaborative connectivity with these key stakeholders, and a focused regional regulatory approach to supporting country and regional business objectives. Can also represent GRA within the region through matrixed involvement with global technical and/or functional GRA departments.

Reporting Relationships
  • Global Head, Regulatory Affairs
  • Indirect reporting line to VP Commercial US & Americas
Main Responsibilities and Accountabilities
  • Provide a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, developing innovative solutions to minimize costs, yet deliver on company strategies and proactively influencing the global regulatory strategy.
  • Contribute to company Global Regulatory Strategy through participation on the Global Regulatory Affairs Leadership Team (GRALT) and SMRT.
  • Work closely with the Global Head,l Regulatory Affairs to maintain an effective Global Regulatory Affairs organization.
  • Provide strategic leadership of Seqirus product development and registration projects to meet the global business objectives for the region.
  • Actively contribute to the global regulatory community through designated projects. Build and maintain relationships with Global Regulatory Affairs at different sites across the Seqirus organisation.
  • Ensure and monitor local registration activities including the development of processes to ensure efficient and timely registration of new products and maintenance of existing products.
  • Ensure strategic input from the Americas Region is provided at GRAST meetings and key information/learnings from GRAST meetings shared back
  • Ensure the timely and efficient identification of regulatory risks associated with the products and issues relating to emerging regulatory environment changes and escalation to Global Head of RA and as appropriate to senior management.
  • Ensure high quality, right first time submissions in line with corporate objectives; managing major and minor applications to meet business objectives and timelines with competitive outcomes in the region.
  • Oversee the development of strong working/partnering relationships with key agencies in the region, usually working through the local country regulatory managers/consultants (i.e. FDA, Health Canada(BGTD),LATAM (ANVISA etc))
  • Full compliance with all government regulations and corporate policies including oversight of corrective actions for which the regional regulatory team is accountable
  • Single point of contact for integration of Regional, Country and Seqirus Business Unit regulatory activities. A recognized regional partner for other regional focused business activities and initiatives
  • In collaboration with Healthcare Policy and External Affairs, advocate for Seqirus by building strong relationships with key external stakeholders (e.g. trade associations and professional bodies). Work externally to influence the regulatory environment in line with Seqirus and where appropriate CSL policy priorities
  • Direct working relationships with the regional/global clinical and technical R&D associated assigned with the region
  • Direct the growth and professional development of the regional Regulatory Strategy team members, including succession planning for critical roles with the regional and global regulatory leadership
  • Regionl Heads Coordinator: establishes and leads a regional forum consisting of all GRA Region Heads to align on direction and priority for GRA policy activities.
  • GRA External Relations & Policy Coordinator: sets direction for GRA policy activities and coordinates trade association engagement and direction with Healthcare Policy and External Affairs, drives global regulatory advocacy activities for Seqirus by building relationships with key external stakeholders (e.g. trade associations and professional bodies) in collaboration with other Region Heads and the Global Head of RA
  • Manage activities of the Region including resources, budgets, information management systems and planning in line with the Global Regulatory Affairs activities
  • Driving Performance- Sets clear expectations/objectives aligned with Seqirus Company Objectives
  • Building Productive Teams- On-boards new hires
  • Perform Site Head duties, including be GRA local contact at the site for site related topics (e.g. coordination of office space, ensuring that GRA staff work practices are in line with HSE requirements and initiatives, local HR related projects etc.) and fostering close collaboration between the GRA departments at the Site.
Position Qualifications and Experience Requirements
  • A degree in Biological or Medical Science or Pharmacy, preferably with a post graduate qualification
  • At least 10 years of regulatory experience, supported by additional pharmaceutical/industry experience
  • Extensive experience at a senior level in Regulatory Affairs, with a strong knowledge of regulatory affairs legislation and processes in the US
  • Demonstrated experience across drug development and commercialization lifecycle, with proven examples of contribution
  • Regional regulatory experience including knowledge of and application submission processes and product life cycle management activities with biological products
  • General management experience with line management and leadership at senior management level is essential
  • Demonstrable experience of effective delivery of objectives in a complex matrix environment
  • Demonstrable experience in establishing and building a high performing team essential, and specifically a RA team highly desirable

THE ROLE MAY BE BASED IN CAMBRIDGE, MA OR SUMMIT, NJ.


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