Job Detail

Req #: 1804441


Location: Boudry, Neuchatel, Switzerland


Job Category: Regulatory Affairs


Work Location: Route de Perreux 1 2017


Organization: Regulatory Affairs


Employee Status: Full-time


Job Type: Regular


Other Locations: United Kingdom--Hillingdon

Here is an exciting opportunity to contribute to the development, execution and delivery of EU regulatory strategy for assigned projects. 

As the person responsible for building regulatory dossiers, you will seek to achieve timely regulatory approvals and maintenance of the existing product portfolio. 

In this role, you will liaise with Regulatory Strategy Leader, Regulatory Affairs (RA) Projects Team management, as well as with other internal/external stakeholders.

Please note: This person can be located in either Switzerland or the UK

Core Responsibilities

• Responsible for, or contributes to,  execution of development and submission strategies in EU for projects assigned.


• Works with Regulatory Strategy Leader & Regulatory Projects Team leadership to ensure that development programs & product life-cycle plans are aligned with regulatory requirements.


• Contributes to the assessment of the pros, cons & risks associated with regional strategic options for projects assigned.


• Contributes ideas to the design of innovative regulatory pathways.


• Supports Regulatory Projects Team Leadership on development of regulatory tactics to be communicated to internal stakeholders, e.g. GPT as requested

• May interface between global & regional headquarters to ensure both parties are kept updated on regulatory progress & operational issues. Participates in global regulatory Therapeutic Area (TA) team.


• Develops & contributes to the development of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, MAAs & variations), ensuring compliance with regulatory requirements.

• Develops content of regulatory documents working with other functions as necessary & contributes to review of documents before submission.

• Reviews draft protocols, acts as Regulatory Project Team representative in clinical study teams and liaises with the Clinical Trials Applications (CTA) group.

• Acts as subject matter expert on designated studies in the event of a Health Authority inspection.


• Responsible for the delivery of Content Plans to allow publishing & timely dossier submission.

• Responsible for tracking & communicating regulatory activities within RA & for accurate submission plans in eQRMS.


• Identifies & communicates to manager, any emerging issues that may impact Celgene’s business.


• Responsible for or participate in interactions with Regulatory Authorities, including agency meetings.


• Supports or is responsible for the optimisation of product information achieved through negotiation with internal stakeholders & Regulatory Authorities.


• Supports or may be responsible for ensuring that Celgene fulfils Health Authority commitments.


• Participates in regional launch team

• Responsible for the regulatory review & approval of commercial advertising & promotional literature


• May be responsible for leading, managing & coaching Regulatory Projects Team staff as assigned.


• Monitors resource needs for projects assigned through discussion with manager.


• May contribute to planning & monitoring the budget for the TA Regulatory Projects Team.


• Identifies any learning or best practice & communicates to manager.


• Responsible for maintaining knowledge of current EU regulatory guidance & procedures


• May participate in cross-functional initiatives.

• International travel may be necessary.

Key Requirements/Knowledge

• 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 EU 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 TA for projects assigned


• 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.


• Line or matrix management experience desirable

Competencies/Skills

• Actively engages in professional development


• Seeks opportunities to learn from others


• Effective project manager, developing leader.


• Creates project plans, prioritises effectively, leads teams in project execution & delivery


• Ability to lead complex 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


• Exhibits consistent professional behaviours

Prerequisites

• Bachelor’s degree in scientific discipline or equivalent


• Essential to have experience of European regulatory processes


• Coming from an "industry" background, you will have a demonstrable track record of strategic Regulatory Affairs


• With strong communication skills and leadership abilities, you are a versatile individual who can "drive projects forward"


• Experience in Haematology/Oncology or Inflammation/Immunology drug development preferred

About Us




COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE



At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.




"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."



There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.