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At Chugai Pharma Europe, we believe in the Power of Together. We know we can achieve more when we work in partnership, collaborate smartly and share expertise and experiences. We are proud to work closely with business partners and each other to bring new medicines to patients across Europe and beyond.
Collaboration, People, and Excellence are at the heart of what we do.
- Member of EU Regulatory Affairs Department providing regulatory intelligence, advice and support to Chugai Pharma Europe (Development Division and Commercial Division) and Head Office (Chugai Japan) as required.
- Act as EU Regulatory Leader (LRL) or provide support to LRL for development projects (NMEs of biologics) across a variety of therapy areas, including clinical trial applications/ maintenance activities, Orphan Drug Designations, Paediatric Investigations Plans etc.
- Define and deliver EU (as LRL or supporting LRL), regulatory strategies for projects, particularly focussing on early development up to clinical proof of concept (PoC).
- As required, support communications with EU Health Authorities, including scientific advice meetings with EMA and/or EU Competent Authorities.
- Provide EU regulatory support for marketed product licenses in UK and Ireland.
- Member of a Regulatory Affairs Function Team (RAFT) providing support to Global Project Teams (GPTs) as required.
- For EU development activities, lead and/ or support planning, preparation, coordination, review, QC and submission of regulatory submissions for EU (and any other responsible countries/territories) e.g. Clinical Trials Authorisations, Orphan Drug Designations, Paediatric Investigations Plans etc.
- Lead and support for maintenance activities for marketed product licenses in UK and Ireland, including:
- Preparation, review and QC of submission dossiers.
- Maintain product information documents online for all licensed products in UK and Ireland.
- Co-ordination and payment of licence fees (UK and Ireland).
- Liaise with supply chain and PV as necessary.
- Any other support, as required.
- Provide on-going local regulatory intelligence related to specific project and therapy area/indication, as well as other changes in local RA environment that might impact RA strategy or plan.
- Main contact and support for regulatory information systems (including XEVMPD).
- Provide project updates to RAFT, GPT, EU management, Global RA and others as required.
- To represent the opinions and advice from CPE regulatory group in meetings, internal and external.
- Interact with R&D personnel in assessing and reviewing data for regulatory submissions.
- Participate in filing and archiving activities, complete relevant trackers on a regular basis.
- Participate in drafting, review, revising SOPs, WPs or other documents applicable to the company.
- Ensure compliance with the quality management system and represent the company if required to be interviewed during agency inspections and the like.
- Support the development of other colleagues in the Group.
- Attend/present at global or local company or external meetings.
- Membership of external industry groups/working parties etc.
Actively embraces and positively demonstrates Chugai’s values
Accountability: We take personal ownership for delivery
Quality: We continually strive to deliver the best solutions
Agile and Responsive: We make things happen
Trust and Respect: We treat and value each other as equals
Working Together: We are a team of individuals focussed on a shared future
Valuing Partnership: We look for win-win solutions in all our business relationships
- Chemistry, Pharmacy or Life Science graduate with appropriate postgraduate life science and regulatory affairs experience (including higher degree in a relevant subject or Diploma in Regulatory Affairs or Management).
KNOWLEDGE, EXPERIENCE & SKILLS
- Appropriate previous regulatory experience within the bio/pharmaceutical industry, in EU regulations covering development through initial licensing.
- Experience in regulatory activities for drugs in development such as clinical trial authorisation applications and scientific advice procedures, ideally in the EU, and including with EMA.
- Experience or familiarity with post-marketed product maintenance activities (especially UK and Ireland) is helpful.
- A general understanding of product life cycle management.
- Proficient in the use of MS Word, Excel and PowerPoint. Able to adapt to new IT systems and programmes quickly with appropriate training.
- Good knowledge of Pharmacovigilance practices and processes.
- Works independently/autonomously within scope of role and engages industriously with team working processes.
- Collaborates and co-operates with management, colleagues and partners.
- Shares experience/expertise with others.
- Demonstrates a positive can-do attitude.
- Creates an open and trusting environment where confidential/ethical issues can be discussed candidly.
- Displays a professional image and acts as a company ambassador.
- Prepared to give a helping hand and participate at all levels of activity within department and company.
- Organised, methodical and shows attention to detail.
- Able to plan own work and organise time accordingly, following consultation with line management.
- Ability to complete defined tasks with minimal oversight and proactively report on progress.
- Logical and analytical thinker.
- Good written and interpersonal communication skills, including negotiating and influencing.
- Good team player.
- Willingness and ability to travel to Japan, US and other destinations as required for business needs.
If you’d like to apply, click here with a copy of your CV and a covering letter explaining your suitability for the post you are interested in.
Chugai Pharma UK was listed in the UK’s Best Companies Index and awarded one star in 2020, scoring highly for its leadership, team and wellbeing initiatives and voluntary initiatives.
Employees are actively encouraged to take time to volunteer, with paid time available for all staff who want to work within a charity. Fundraising events are also organised – last year a team of employees completed the Gung-Ho© charity event for Children In Need and each office works closely with charities in their local area. For example, in the UK the team has worked with Winston’s Wish, who support children and young people after the death of a parent or sibling.
In 2020, Chugai has chosen Hope and Homes as its European charity of the year. Hope and Homes are working towards a day where orphanages have been eliminated for good.
“Chugai wants its staff to build their careers with the company and as a young professional I have a lot of room for growth.”
Alice, Senior Medical Manager, CPU
“Chugai believes strongly in the potential of people. We are flexible, curious, willing to adapt to new situations and always looking for new opportunities.”
Florian, Business Development Manager, CPE
“I am proud to be part of a company with a strong future ahead that always keeps patients in mind. We want to build a future that is focused on improving patient care and treatment.”
Remi, Head of Regional Market Access & Business Development, CPF