Regulatory Affairs Officer
1 day left
- Experience Level
- Experienced (non-manager)
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.
We are proud to announce that Chugai Pharma Europe and Chugai Pharma UK are officially
Great Place to Work-Certified TM companies!
The RA Officer will be a member of our EU RA Department providing regulatory intelligence, advice and support to Chugai Pharma Europe and Head Office (Chugai Japan) as required. They will act as EU Regulatory Leader (LRL) or provide support to LRL for development projects (NMEs of biologics) across a variety of therapy areas. They will define and deliver EU regulatory strategies for projects, particularly focussing on early development up to clinical proof of concept (PoC). As required, they will support communications with EU Health Authorities, including scientific advice meetings with EMA and/or EU Competent Authorities. They will also 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:
- Prepare, 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.
- 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.
- 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 QMS 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 and/or present at company and external meetings.
- Membership of external industry groups/working parties etc.
- 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).
- 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.
- Ability to work independently/autonomously within scope of role and engage industriously with team working processes.
- Collaborate and co-operate with management, colleagues and partners.
- Demonstrate a positive can-do attitude.
- Create an open and trusting environment where confidential/ethical issues can be discussed candidly.
- Display a professional image and acts as a company ambassador.
- Organised, methodical and shows attention to detail.
- Logical and analytical thinker.
- Good written and interpersonal communication skills, including negotiating and influencing.
- Willingness and ability to travel to Japan, US and other destinations as required for business need.
Please send your Cover Letter and CV to:
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