- Contributes to the development of the global regulatory strategy and executes regulatory strategies for assigned projects
- Preparation of regulatory submissions including: INDs, CTAs, GMOs, IDEs, amendments, annual reports, meeting briefing documents, responses to regulatory agency information requests, marketing authorization applications, and other regulatory submissions, as applicable.
- Serves as the primary liaison with FDA and other regulatory agencies throughout development of projects, including support for regulatory agency meetings and teleconferences
- Identify and assess existing and new regulations, guidance documents, international standards, or consensus standards; and provide interpretive guidance and ensure applicable implementation into development planning and execution
- Ensures that all regulatory activities and documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance to facilitate agency review and acceptance
- Represents Global Regulatory Affairs as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective in team meetings
- Reviews and establishes standard operating procedures (SOPs) and global regulatory affairs processes
- Ensure regulatory documentation is maintained appropriately
- Other duties as assigned
Qualifications & Experience - Bachelor's Degree required; advanced degree preferred
- Experience in drug development process
- Minimum 3 years of Regulatory Affairs experience
- Must have experience filing regulatory dossiers (CTAs, INDs, IMPDs, IDEs)
- Solid working knowledge of relevant domestic and global regulations and guidance Desirable
- Experience in cell and gene therapy and/or oncology is strongly preferred
- Experience with BLAs/NDAs/MAAs preferred
-
Pa - Hybrid Role
1 week ago
Niche Recruitment Ltd Cirencester, United KingdomWe are keen to speak to you if you have recent experience as a PA (Personal Assistant) or EA (Executive Assistant). · **In support of the Head of Department, the PA/ EA will**: · - Manage an incredibly busy diary to facilitate both professional and personal responsibilities · - A ...
-
Senior Regulatory Affairs Manager Hybrid
1 week ago
Vodafone Newbury, Berkshire, United KingdomLocation: Newbury or London, Hybrid working · Excellent basic salary plus bonus and Vodafone benefits · Working Hours: Full time 37.5 hours per week - Mon to Fri · Hybrid · Our blended working approach allows our people to work both in the office and at home, providing the fl ...
-
Assistant Accountant
1 week ago
Wade Macdonald Abingdon, United Kingdom**Assistant / Part-qualified Accountant (Full Time)** · Abingdon, Oxfordshire · £30,000 - £40,000 (dependent upon experience) + study support + hybrid working · Wade Macdonald is currently recruiting a part-qualified accountant for a rapidly growing outsourced business services c ...
-
Associate Director, Regulatory Operations
3 days ago
Adaptimmune Abingdon, United Kingdom**Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K. and biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and all ...
-
Treasury Assistant
1 week ago
Wade Macdonald Abingdon, United Kingdom**Job details**: · - Posted 17 March 2023- Salary £ £26000 per annum- LocationAbingdon- Job type Permanent- DisciplineTax & Treasury- Reference29190/001_ Contact NameEllis Bradley**Job description**: · **Treasury Assistant - Abingdon - £26,000 - Hybrid** · *** · **The Company** · ...
-
Electoral Services Officer
1 week ago
South and Vale District Council Abingdon, United Kingdom Full timeElectoral Services Officer · Location: Hybrid. The designated office base is Abbey House, Abingdon. The councils operate in a truly flexible, and hybrid way where the focus is on outcomes not where you work. · Salary and grade: £42,576 – £48,530 per year, Grade 6 · Duration of ro ...
-
Credit Controller
1 week ago
FryerMiles Recruitment Abingdon, United KingdomFryerMiles have an exciting opportunity for a Credit Controller to work with a client of ours based in Abingdon on a 6 month contract. The client offers hybrid working (3 days in the office, 2 days per week at home). · This is a great chance to work with a large US listed company ...
-
IT Administrator
2 days ago
The Curve Group Abingdon, United Kingdom**IT Administrator - 4 month Fixed Term Contract - Hybrid** · Our client, a growing biotechnology research organisation is looking for an IT Administrator to join their Oxfordshire based team for a 4 month FTC. · This person will play a key role in supporting the IT operations of ...
-
Systemic Family Therapist
3 days ago
Oxford Health NHS Foundation Trust Abingdon, United Kingdom**Are you a Family Therapist looking for your next role, with an opportunity for Hybrid **working (face to face and remote working)? If so, then we have a great role for you** · You will have the opportunity to join the Oxford South Getting More Help (CAMHS) Service. We have a re ...
-
Credit Controller
1 week ago
Page Personnel Finance Abingdon, United KingdomThis is an exciting opportunity for an immediately available Credit Controller to join an established business in Abingdon on a temporary basis with the opportunity for hybrid working available. · **Client Details** · The client is a growing business with a global presence based ...
-
Senior Accounts Assistant
1 week ago
Page Personnel Abingdon, United KingdomOn-site parking · - Varied role · **About Our Client**: · The client is established in their field and experiencing a period of growth as they commence a new exciting project. They are based on a site close to public transport links and hybrid working will be considered after an ...
-
Civilian Dental Practitioner
1 week ago
Ministry of Defence (Defence Medical Services) Abingdon, United KingdomDuties and responsibilities for the role include but are not limited to: Inspecting all personnel for whom they are responsible at intervals in line with The National Institute for Health and Care Excellence guidelines and providing follow up treatment as required. Ensuring that ...
-
Human Resources Advisor
1 week ago
Trinity Fire & Security Systems Ltd Abingdon, United Kingdom**The Company**: · **The Role** · To help provide a generalist HR service to multiple functions and teams across Trinity. · This is a newly created role to support the HR Business Partner with the full breadth and depth of HR in a growing business (circa 500 headcount). · Given t ...
-
Senior Accounts Payable Clerk
23 hours ago
Page Personnel Abingdon, United KingdomHybrid working available · - Immediate start · **About Our Client**: · The client is renowned in their field and is a rapidly growing company with an international presence. Based in a location with good transport links. · The Senior Accounts Payable Clerk will be responsible for ...
-
Sports & Community Fundraiser
1 week ago
Against Breast Cancer Abingdon, United KingdomAs Sports & Community Fundraiser you will be responsible for: · - Helping to plan, deliver and evaluate our events programme · - Being responsible for the administration of all Sport & Challenge events · - Being the first point of contact for new Sport & Challenge event enquiries ...
-
Administrator - Business Services - Bournemouth
2 hours ago
Cafcass Abingdon, United KingdomWe are recruiting for the role of **Business Services Officer** in our team covering **Bournemouth.** · We trust and empower colleagues to work in a hybrid way, providing the resources, equipment, and support, so that individually and collectively, we can be the voice of children ...
-
Graduate Accounts Payable Assistant
2 days ago
Morgan McKinley Abingdon, United KingdomMorgan Mckinley are working exclusively with a fast growing leading company based in Abingdon. · **ABOUT THE COMPANY**: · The company are market leaders in what they do and are continuing to grow. They offer excellent benefits, hybrid working, study support and opportunities for ...
-
Administrator - Business Services - Oxford
2 hours ago
Cafcass Abingdon, United KingdomWe are recruiting for the role of **Business Services Officer** in our team covering **Oxford.** · We trust and empower colleagues to work in a hybrid way, providing the resources, equipment, and support, so that individually and collectively, we can be the voice of children and ...
-
Accounts Receivable Administrator
1 week ago
Page Personnel - UK Abingdon, United KingdomHybrid working available · - Immediate start · **About Our Client**: · The client based in Abingdon is a leading supplier in the science and innovation industry with a global presence. · - The Accounts Receivable Administrator will: · - Produce invoices, statements upon Customer ...
-
Customer Service Executive
1 week ago
Alamy Abingdon, United Kingdom**Customer Service Executive** · Would you like to join Alamy as a Customer Service Executive where you can contribute value and benefit from exceptional training and development opportunities? · **About us** · We're Alamy, the world's most diverse stock photo library with over 2 ...
Manager, Regulatory Affairs-hybrid role - Abingdon, United Kingdom - Adaptimmune
Description
PRIMARY RESPONSIBILITY
Under the supervision of Senior Regulatory Affairs staff, the Manager, Regulatory Affairs is responsible for developing, implementing, and leading short- and long-term global regulatory strategies that support the success of products throughout their lifecycle. Serves as the primary liaison to regulatory agencies and leads submission activities to regulatory agencies. Identifies and assesses regulations and guidance documents provides interpretive guidance applicable implementation. This position will work within cross-company development project teams and will provide regulatory expertise into strategic regulatory plans.
Key Responsibilities
Required
&v=024){kind=logo}
