Senior Manager, Regulatory Projects Team - Switzerland
Contributes to the development, execution & delivery of EU regulatory strategy for assigned projects. Responsible for the building of regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing product portfolio. Liaises with Regulatory Strategy, (RA) Franchise Team management & with other internal/external stakeholders. May be responsible for managing & developing staff.
Responsibilities will include, but are not limited to, the following
· Contributes to 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
· Works with Regulatory Franchise Team Leadership to ensure that EU regulatory product strategy and deliverables are developed in alignment with Global Regulatory Affairs (GRA) and the Global Project Team (GPT)
· Maintains awareness of emerging issues that may impact regulatory product strategy and Celgene EU regional business. Proposes adjustment of the strategy and implementation plan in response to new information or changes in the competitive landscape and consults with management
· Maintains knowledge of current EU regulatory guidance and procedures and reviews new guidance for impact on regulatory product strategy and discusses with management.
· Works with Regulatory Franchise Team Leadership to ensure that 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
· Responsible for or contributes to the execution of regulatory product strategy and for achieving timely regulatory approvals with competitive product labels and the maintenance of licences for products assigned.
· Working with other functions as necessary, contributes to 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. Contributes to the review of key documents before submission.
· Responsible for or participates in interaction with the with the European Medicinal Agency (EMA), and National Regulatory Health Authorities within the EU for product related discussions
· Supports or may be responsible for ensuring that Celgene fulfils Health Authority commitments.
· May represent RA at Governance Committees
· May be responsible for ensuring that GRA, GPT, RA EMA Labelling, Regulatory Operations and Affiliate Regulatory are kept updated in a timely manner, on regulatory product plans progress and operational issues.
· Reviews draft protocols, acts as Regulatory Franchise Team representative in clinical study teams and liaises with the individuals with CTA or CRO oversight responsibility.
· Acts as Subject Matter Expert on designated studies in the event of the Health Authority Inspection.
· Responsible for the delivery of Content Plans to allow publishing and timely dossier submission
· Responsible for tracking and communicating regulatory activities within RA and for ensuring that submission plans are captured accurately.
· May participate in Global Regulatory and Global/Regional Disease Teams or Launch Team(s) as required.
· May be responsible for the regulatory review and approval of commercial advertising and promotional literature.
· May have responsibility for leading, managing, developing and coaching regulatory staff and may act as a mentor for other RA team members.
· Monitors resource needs through discussion with manager.
· May contribute to planning and monitoring the budget for the assigned projects.
· Identifies any learning or best practice within RA EMEA group and communicates to manager.
· May participate in cross-functional initiatives.
· International travel may be necessary.
· Bachelor’s degree in scientific discipline or equivalent required.
· Experience in EU Regulatory Affairs & recent experience of EU Centralised Procedure required.
· In-depth knowledge of current regulatory requirements essential
· In-depth understanding of CTD modules; non-clinical, CMC, Clinical
· Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required.
· Knowledge of Therapeutic area for assigned projects
· Experience of leading projects through Regulatory Procedures
· Experience in Haematology/ Oncology or Inflammation/ Immunology preferred
· Experience of contributing to Ph III protocols & able to contribute to clinical development plans.
· Actively engaged in professional development
· Seeks opportunities to learn from others
· Effective project manage, developing leader. Creates project plans, prioritises effectively, leads teams in project execution & delivery
· Ability to lead routine regulatory submissions. Leads activities for assigned projects
· Demonstrates appropriate decision making
· Conveys trust in others’ knowledge, skills & judgment & provides team members with appropriate levels of autonomy & decision-making authority.
· Displays a willingness to challenge the status quo & take risks
· Acknowledges others who take the initiative to try new approaches even if the results are not perfect
· Identifies when to escalate issues to line management & knows when to seek advice.
· Communicates complex ideas effectively across a culturally diverse environment
· Communicates effectively with Regulatory Authorities as required
· Obtains alignment through effective communication
· Ability to influence internal & external stakeholders to obtain desired outcome.