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The Regional Regulatory Disease Lead (RRDL)/Regional Product Lead (RPL) is the EU regulatory expert for the assigned therapeutic area(s) (TA) or product(s). This role is accountable for the development of regulatory product strategy and execution, achieving timely regulatory approvals with competitive product labels and also for the maintenance of the existing product portfolio. This role is responsible for managing, developing and coaching regulatory staff and for the budget and resource planning for the group assigned. The RRDL/RPL will be a member of the Europe, Middle East and Africa (EMEA) Regulatory Affairs (RA) Franchise Leadership team and may be a member of other EU/Global cross-functional teams.
Responsibilities will include, but are not limited to, the following
• Acts as the EU regulatory expert for the assigned therapeutic area(s) or product(s) and retains the strategic and operational overview across multiple projects avoiding strategic or operational conflicts.
• Accountable for the development of EU regulatory product strategy based on Celgene strategic imperatives, product knowledge, global and regional regulatory requirements, including assessment and inclusion of innovative regulatory pathways to achieve regulatory approvals meeting business needs.
• Accountable for ensuring that EU regulatory product strategy and deliverables are developed in alignment with Global Regulatory Affairs (GRA) and the Global Project Team (GPT).
• Accountable for the maintenance of regulatory product strategy, proactively identifying emerging issues that may impact regulatory product strategy and the Celgene EU regional business. Adjustment of the strategy and implementation plan in response to new information or changes in the competitive landscape. Communicates issues to management as appropriate.
• Maintains knowledge of current EU regulatory guidance and procedures and works with the Regulatory Intelligence and Policy (RIP) Group in assessing newly issued Health Authority guidance to ensure impact and strategic recommendations are included in the regulatory product strategy.
• Ensures product development programs and life-cycle plans are aligned with Celgene strategic oversight, business model, Global and EU regulatory requirements.
• May have global responsibility for specific projects which will require; a knowledge of global regulatory requirements, development and ownership of the Regulatory Development Plan (RDP), responsibility for Worldwide submission plans and accountability for global regulatory documents such as clinical trial/marketing applications and for interactions with global Health Authorities.
• Accountable for the execution of regulatory product strategy and for achieving timely regulatory approvals with competitive product labels and the maintenance of the existing product portfolio.
• Accountable for the preparation and content of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, paediatric waiver requests, MAAs and variations), ensuring compliance with regulatory requirements. Reviews and approves key documents before submission.
• Accountable for ensuring that submission plans are captured appropriately.
• Responsible for the interactions with the European Medicinal Agency (EMA), and National Regulatory Health Authorities within the EMEA region for product related discussions.
• Responsible for the organisation of ad hoc Regulatory Advisory Boards as required.
• Accountable for tactical regulatory input to internal teams (such as Medical Directors meetings, GPT, EU/global disease teams).
• May represents RA at Governance Committees
• Accountable for ensuring that GRA, GPT, RA EMEA Labelling, Regulatory Operations and Affiliate Regulatory are kept updated in a timely manner, on regulatory product plans, progress and operational issues.
• May engage with Regulatory Agency(ies) on Disease or Product related policies in collaboration with Regulatory Strategy and RIP groups.
• Leads or participates in Global Regulatory and Alliance Teams and participates in Global/Regional Disease Teams and Global/Regional Launch Team(s) as required.
• Responsible for leading, managing, developing and coaching the regulatory team assigned. May act as a mentor for other RA team members.
• Responsible for work force planning and monitoring for assigned projects, identifying and communicating changes in resource needs to management.
• Responsible for planning and monitoring the budget for the assigned projects and team.
• Responsible for implementation and monitoring compliance with the Celgene travel policy for the assigned team.
• Contributes to the development and communication of best practice within RA EMEA group and ensures any learning or best practice is implemented within the Regulatory team.
• May lead or participate in cross-functional initiatives.
• May lead or participate in industry initiatives, e.g. workshops, sessions at symposia
• Will be a member of RA EMEA Franchise leadership team.
• Bachelor’s degree in scientific discipline or equivalent required; advanced degree preferred.
• Extensive experience in the pharmaceutical industry, including a good understanding of the drug development process and the roles of the different functions and stakeholders involved.
• Significant experience in European RA with an in-depth knowledge of the EU centralised process and direct experience of leading regulatory strategy development and execution required.
• In depth knowledge of current global regulations and guidances (e.g. EU, ICH etc) essential as they relate to the overall global regulatory strategy.
• Regulatory experience and knowledge in multiple phases of drug development across various therapeutic areas, with expertise in Haematology/Oncology or Inflammation/ Immunology required.
• Demonstrated experience in strategic planning, preparing and leading complex global dossier submissions (e.g. US, EU. etc.)
• Proven success matrix management required and experience with direct report supervision preferred.
• Demonstrated ability to effectively lead, coach and mentor colleagues.
• Ability to anticipate future needs when selecting and developing talent (e.g. develops successors and talent pools for key positions).
• Excellent organisational and time management skills needed to manage multiple ongoing projects simultaneously.
• Excellent interpersonal skills in oral and written communication and effective presentation to clearly articulate ideas, opinions and information across GRA and different functions within the organisation.
• Demonstrated ability in data interpretation, to use and understand scientific data and contribute to study designs, drug development and commercialisation plans, ensuring better regulatory outcomes.
• Demonstrated ability to anticipate, analyse and resolve regional/global regulatory related problems.
• Displays a willingness to challenge the status quo and take risks through innovation.
• Strong negotiation and influencing skills
• Results driven and team orientated with the ability to influence outcomes.
• Good listening skills and a strong willingness/desire to help resolve issues faced by others around them.
• Cultivates internal and external networks of people across a variety of functions and locations.
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