Maidenhead, Berkshire, ENGLAND, United Kingdom
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), Maidenhead (UK), Amsterdam (Netherlands) or Parkville (Australia), we are looking for a:
Head, Global Strategic Labeling
The Head, Regulatory Affairs-Global Strategic Labeling is responsible for all aspects of labeling, advertising and promotional regulatory functions. This position will include providing strategic regulatory direction to the senior leadership leading the design and execution of regulatory strategies and oversight of the end to end labeling process to facilitate timely marketing approvals and product labeling (prescribing information, patient information) compliance for Seqirus. The Head, Global Strategic Labeling leads processes for effective submission planning and delivery including the preparation and review of all regulatory submissions documentation related to product labeling and the company core data sheets, carrying out gap analysis, ensuring compliance with required regulations, and in association with the RA Heads of Regions, communicating with the FDA, EMA, the TGA and other global Health Authorities.
This role reports to the Global RA Head, Development and Strategy
This role has 3 to 6 direct reports (including Head, Labelling Operations; Head, Promotional Materials and Medical Copy Clearance Review & Head, Product Labelling) and up to 6 indirect reports.
Close working relationship with RA Heads of Regions, Regulatory Operations, Clinical Development, Clinical Safety & Pharmacovigilance, Medical Affairs, Commercial Operations and Manufacturing Operations, Supply Chain (Printed Materials)
Represents the company at Regulatory Agency meetings relating to proposed or new Labelling Requirements.
Location: Seqirus Office where collocated with Clinical Development, Clinical Safety/Pharmacovigilance, Medical Affairs& Commercial Operations and if possible the Printed Materials Group.
Working hours – 10 day fortnight
Domestic and international travel will be required, and flexibility to accommodate working across timezones is required.
Is Secretary of the Global Labelling Committee, and in this role develops robust systems and processes for the compilation, maintenance and review of the Company Core Data Sheet, and compliance of the processes in accordance with GxP requirements.
Leads the process for the consolidation and review of the TPP and the Company Core Data Sheet through all stages of the development lifecycle, in association with Clinical Development and Clinical Safety, NonClinical Development, Medical Affairs and Commercial.
Develops and implements global & local procedures to support the preparation and approval of marketed promotional materials, especially with respect to FDA.
Oversight of the regulatory aspects of the promotional review / approval process for product promotional materials. Ensures compliance of promotional materials with governing FDA regulations, and ensure submission of promotional materials to OPDP in a timely fashion.
Leads the design and implementation of regulatory labelling approval strategies and ensures regulatory milestones are met to support the business goals of the company.
Leads a global team that requires close collaboration and co-ordination with the RA Regions, Heads, Regulatory Operations, Commercial Regions Heads and the Global Core Project Team to ensure an optimal global product label.
Develops regulatory strategies to reduce regulatory risks associated with clinical development, clinical safety, nonclinical and CMC sections of the product label; ensures that direct reports work with core project teams to implement them.
Defines content for and directs the organization and preparation of high quality and effective regulatory submissions, relating to product labels and manages the labelling review process.
Develops and oversights the regulatory aspects of the printed materials processes, and ensures the timely approval of seasonal printed materials for Seqirus products.
Leads the process for developing responses to Regulatory Agency questions in relation to the Product Label and provides SME support for GMP and/or GVP inspections relating to the Company Core Datasheet and Labelling process.
Maintains knowledge and monitors changes in pertinent laws, regulations and guidance’s. Interprets external developments and informs/educates stakeholders. Maintains intelligence database of competitor products.
Initiates, educates and drives the process to address new regulatory agency requirements relating to product labelling (eg Pregnancy Use Requirements)
Promotes and supports initiatives to ensure compliance with regulatory and GxP requirements
Prepares and delivers effective presentations for external and internal audiences as needed.
At least 7-10 years’ experience in Regulatory Affairs in the Biological, Pharmaceutical or Biotechnology industry with a proven track record in implementing regulatory strategies for labelling, especially with at least one of FDA and/or EU(National or EMA) regulatory agencies. Sound knowledge and awareness of FDA advertising and promotional regulatory requirements.
Strong knowledge and understanding of the full product lifecycle, through INDs, BLAs, and MAAs and experienced in international regulatory filings.
Direct experience in managing interactions with the international regulatory agencies and an advanced knowledge and utilization of regulations and guidances.
Demonstrated understanding of the compliance aspects of an “end to end” labelling process and ability to support GxP inspections.
Well-developed critical reasoning skills and risk management assessments, and strong eye for detail.
Excellent team interaction skills along with demonstrated ability to work in a cross functional team and influence the decisions of a team.
Demonstrated ability to work in a dynamic environment with a high degree of flexibility.
Demonstrated ability to understand and manage filings and regulatory agency approvals around the seasonal aspects of influenza vaccine manufacture and approval.
Experience in cross functional teams and managing teams or third party consultants desirable.
Strong written and verbal communication skills and presentation effectiveness.