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Head, Seasonal & Pandemic Non Adjuvanted Influenza Vaccines & Rapivad, US & Regions - Cambrindge, MA (USA) - Seqirus

Cambridge, MA - Massachusetts, United States

Posted: 1-Jul-2016

Ref#: 12345696636


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 Seqirus, 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.


Currently for our office in Cambridge (USA), we are looking for a Head, Seasonal & Pandemic Non Adjuvanted Influenza Vaccines & Rapivad, US & Regions

 

Role Overview:

  •  Teams, in the specified region
  • As the SME, this role provides regional specific regulatory advice to the Global Core Project/Global Product Teams and the Global Regulatory Strategy Team
  • May deputise for Regions Head, to lead negotiations with the Regional Regulatory Agencies for the assigned product/portfolio
  • Position may have up to 1- 6 direct reports and up to 4 indirect reports in the regional office
  • Key Relationships: Internal departments including Regulatory Operations, RA CMC, Commercial, QA, QC and Manufacturing Operations., External : Regulatory authorities in the Region, Licensors/partners, Agents/distributors
  • Working hours – 10 day fortnight( can be negotiated), must be flexible to work with offices within regions and at times globally
  • Domestic and some international travel will be required

 

Principal Accountabilities:

Licensed products

  • Formulate, lead and drive the regional regulatory Strategy for Seqirus manufactured products, or influenza products
  • Preparation, compilation and submission of high quality applications including marketing authorisation applications, variations, renewals and responses to regulatory agency reviewer questions
  • Maintain up to date product labelling for all Seqirus territories (PI, CMI, SmPC, PIL etc) including translation requirements and manage regional consultants
  • Ensure dossiers meet content requirements for regions

In-licenced products

  • Formulate, lead and drive the regulatory Strategy for Seqirus in-licensed products
  • Preparation, compilation and submission of high quality applications in Australia/New Zealand (and other territories within the Region as applicable) including Category 1/3 applications, responses to questions and regulatory agency briefing documentation
  • Support business development in the regulatory assessment and due diligence of new product opportunities
  • Maintain up to date product labelling (PI, CMI, etc) for all Seqirus in-licensed products in relevant territories
  • Build strong, credible relationships with licensors/partners

General

  • Actively contribute to the global Seqirus regulatory community through designated projects. Build and maintain relationships with Global Regulatory Affairs across the Seqirus company
  • Gather, analyse and monitor publicly available Regulatory information relevant to Seqirus products and/or specific region requirements/proposed changes and communicate the implications to RA, Regions Head,  and Regions Product Teams ( Commercial, Medical Affairs, Safety/Pharmacovigilance) and Medical Affairs colleagues, and for Inlicensed Products to Inlicensing Partner Companies
  • Lead and oversee the Regulatory activities, which include but are not limited to submissions planning, regional specific labelling, and other activities as assigned
  • Work closely with the RA Regions Head to develop and maintain an effective Global Regulatory Affairs organization through continuous improvement initiatives that deliver business excellence
  • Manage the functional budget, resource plans and monitor progress to ensure strategic objectives of the Region are achieved
  • Manage training and development of staff to maximise their skills and abilities and optimise outcomes for Seqirus
  • Deputise for RA, Regions  Head as required
  • Represent Seqirus at meetings with Regulatory Agencies
  • Manage the contractual arrangements with contractors and partners/agents for Seqirus products
  • Maintain awareness of and expertise in TGA, ICH, FDA and EU guidelines relevant to role
  • Oversee the development of strong working/partnering relationships with regional regulatory agencies in terms of new submissions initiatives by working through the local country regulatory managers/consultants (i.e. FDA, Health Canada, EMA, TGA). Represent Seqirus at meetings with Regulatory Agencies
  • Manage the contractual arrangements with service contractors to ensure full compliance with all government regulations and corporate policies

 

Educational Requirements:

  • Tertiary qualification preferably in biological or health sciences, pharmacy or related field

 

Required Experience:

  • At least 3- 5 years of regulatory affairs experience preferred, although experience in achieving a new Marketing Authorisation in the US, EU or Australia will also be considered favourably
  • Understanding of scientific principles relevant to the development of a pharmaceutical product
  • Understanding of the principles of GxP
  • Demonstrated ability to lead, influence and motivate a team (evidenced by managing direct reports or RA lead in a cross functional project team)
  • Demonstrated ability to deal with rapid change
  • Ability to establish credible relationships within Seqirus and externally
  • Demonstrable experience of effective delivery of objectives in a complex matrix environment
  • Ability to lead, influence and motivate a team is desired
  • Demonstrated ability to deal with rapid change
  • Customer service focus
  • Demonstrated sound judgement and flexible approach to managing situations
  • Ability to identify “big picture” and opportunities/major issues and link day to day tasks with long term goals
  • Planning, organising and time management skills
  • Problem solving and analytical skills
  • Effective verbal and written communication skills in a cross functional environment
  • Effective presentation skills
  • Attention to detail
  • Computer literacy
  • Ability to establish credible relationships within Seqirus and externally

If you feel that your profile is in line with the role scope and you would like to apply for the opportunity, please send your CV to fabian.wawrzyczek@seqirus.com


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