Senior Regulatory Affairs Manager - European Project Lead
Other Locations:UK- Stockley Park; Switzerland- Boudry DescriptionCelgene 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.Core ResponsibilitiesResponsible 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/KnowledgeBachelor'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/SkillsActively 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
PrerequisitesBachelor'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