Project Manager, Regulatory Affairs

AbbVie
Taplow
2 days ago
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  • Implement regulatory strategies & deliverables for a portfolio of products early/late development or marketed products for the Europe Area Regulatory Affairs (ERA) including EU and non-EU countries such as CEE countries, Israel, Turkey, Switzerland and the UK. Include fair representation of the interest of EU countries into Global Regulatory Product Teams in alignment with the overarching global regulatory strategy and region specific requirements.
  • Responsible for assigned product maintenance and lifecycle management submissions, in line with legal/regulatory requirements and regional business needs.
  • Contribute, as required, in the development of regional processes to maximize operational efficiency of regulatory activities within the region.
  • Develops and maintains knowledge of regulatory procedures and environment within the region.
  • Primary RA interface with Commercial Area Brand Team and in collaboration with the RA personnel in the affiliates., Implement regulatory strategies & deliverables including effective planning, tracking, archiving of activities, especially submissions for early/late development and marketed products
  • Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.
  • Supporting the drug development strategy, defining options for including supporting Scientific Advice/PIP/IMPD, creating briefing packages and co-ordinating and leading agency meetings logistics
  • Primary RA interface with Commercial Area Brand Team. Represent RA on Area Brand Teams
  • Provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks
  • Primary interface to and from the RA personnel in the affiliates and provides product updates in Area Regulatory Product Teams (ARPTs)
  • Primary interface with local health authorities (via RA personnel in the affiliates where appropriate)
  • Interface with EMA for products within the Therapeutic Area on behalf of the Product Lead when required.
  • Provide leadership and support to RA personnel in the affiliates through ongoing communication. Assess scientific data provided by specialist units for registration purposes against ERA regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses (including CTAs)
  • Provide Europe Area input on local implications through participation in Teams as needed (e.g. submission teams, labelling working group including development of labelling negotiations).
  • Ensure regulatory compliance within ERA for the assigned compounds/products. Implement remediation plan to address identified gaps, if any.
  • Support development and implementation of new processes and ensure that these meet regional regulations and needs
  • Responsible for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects.


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