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Associate Director, Regulatory Affairs (CH or UK based)

Req #: 17001430
Location: Boudry, NE CH
Job Category: Regulatory Affairs
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene R&D Sarl
Schedule: 37.5
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Director
Travel: Yes, 15 % of the Time
Other Locations:Switzerland- Boudry

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsible for development & execution of EU submission strategy for assigned projects and for building regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing product portfolio. Liaises with Regulatory Affairs (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

  • Responsible 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.
  • Responsible for ensuring that EU regulatory product strategy and deliverables are developed in alignment with Regulatory Franchise Team Leadership, Global Regulatory Affairs (GRA) and the Global Project Team (GPT).
  • Responsible for the maintenance of regulatory product strategy, proactively identifying emerging issues that may impact regulatory product strategy and 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 ensures the impact of new guidance is included in 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.
  • Responsible for the execution of regulatory product strategy and for achieving timely regulatory approvals with competitive product labels and the maintenance of licenses for products assigned.
  • Responsible for the preparation and content of high quality regulatory dossiers (eg.,,

    scientific advice requests, orphan medicinal product designation applications, paediatric waiver requests, MAAs and variations), ensuring compliance with regulatory requirements. Reviews key documents before submission.

  • Responsible for interactions with the European Medicinal Agency (EMA), and National Regulatory Health Authorities within the EU for product related discussions.
  • Responsible for ensuring that Celgene fulfils Health Authority commitments.
  • Responsible for the organization of ad hoc Regulatory Advisory Boards as required.
  • May represent RA at Governance Committees
  • Responsible 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 and for ensuring that submission plans are captured appropriately.
  • May leads or participate in Global Regulatory and Alliance Teams 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.
  • May contribute to work force planning and is responsible for identifying and communicating changes in resource needs to management.
  • May contribute to planning and monitoring the budget for the assigned projects. 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.

Key Requirements/Knowledge

  • Bachelor's degree in scientific discipline or equivalent required
  • Bachelor's degree in scientific discipline or equivalent required
  • Significant experience in the pharmaceutical industry, including considerable period in European Regulatory Affairs with significant recent experience of EU Centralized Procedure required.
  • Expert knowledge of current EU regulatory requirements essential
  • Expert understanding of CTD modules; non-clinical, CMC, Clinical
  • In-depth knowledge of core processes of drug discovery, development, manufacturing & marketing required.
  • Good knowledge of TA assigned
  • Significant experience of leading multiple projects through Centralized Regulatory Procedures
  • Significant experience in Haematology/ Oncology or Inflammation/ Immunology required
  • Significant experience of contributing to Ph HI development plans.
  • Success in matrix management experience required.

Competencies/Skills

  • Actively engages in professional development
  • Effectively manages people & encourages them to seek development opportunities
  • Effective leader. Creates project plans, priorities  effectively, leads teams in project execution & delivery.
  • Experience of leading complex regulatory submissions including MAAs. Leads activities for assigned indications.
  • May have direct line management responsibility and may mentor other RA team members
  • Demonstrates appropriate decision making
  • Conveys trust in others' knowledge, skills & judgment & provides direct reports & 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
  • Escalates issues appropriately & understands how far issues should be escalated
  • Communicates appropriately & effectively internally at all levels of the organization & with external stakeholders
  • Communicates effectively with Regulatory Authorities as required
  • Obtains cross-functional alignment through effective communication.
  • Ability to influence internal & external stakeholders to obtain desired outcome
  • Sets an example by their consistent professional behavior

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