Sr Associate Regulatory Affairs - CMC Job at Amgen (Thousand Oaks)

Sr Associate Regulatory Affairs - CMC

If you feel like you're part of something bigger, it's because you are. At Amgen...

Location

United Kingdom , Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Background in CMC related functions (e.g., Quality, Manufacturing, etc) with limited or no prior Regulatory Affairs experience
Curious, proactive, confident in tackling new challenges, and comfortable working collaboratively in a fast-paced learning environment
Developed project management and organizational skills
Strong and effective oral and written communication skills

Job Responsibility

Contribute as a key member of the global regulatory CMC product team
Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications
Document and archive CMC submissions and related communications in the document management system
Initiate and maintain CMC product timelines at the direction of product lead
Interface with the regulatory operations team
Train staff on select CMC procedures and systems
Provide report status of activities and projects to teams and department
Participate in cross-functional special project teams

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Sr Associate, Manufacturing Regulatory

The Sr Associate, Manufacturing Regulatory Affairs is responsible for supporting...

Location

Italy , Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Degree in Pharmaceutical Chemistry and Technology (CTF), Chemistry, or Industrial Chemistry
A Master's degree in Regulatory Affairs is considered a strong asset
1–2 years of experience in Regulatory Affairs within pharmaceutical companies, preferably in an international environment
Fluent in English (written and spoken)
Good proficiency with standard IT tools and basic statistical analysis
Strong attention to detail and quality-oriented mindset
Proactive, results-driven approach with the ability to manage assigned responsibilities independently
Excellent communication and interpersonal skills
Ability to work effectively in cross-functional teams

Job Responsibility

Assess regulatory impact of changes related to manufacturing sites, processes, and products
Plan and support activities associated with CMC (Chemistry, Manufacturing & Controls) variations and manufacturing site changes
Coordinate the collection, review, and organization of GMP documentation required for regulatory submissions
Draft and review documentation supporting CMC variations and manufacturing changes
Prepare product-specific regulatory declarations and contribute to Product Quality Reviews (PQRs)
Collaborate cross-functionally with Quality, Manufacturing, and other relevant departments to ensure alignment on regulatory strategies and timelines
Support continuous improvement initiatives to ensure ongoing compliance with regulatory standards

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

Fulltime

New

Social Worker – Fostering - Family and Friends Team

Are you passionate about working with Family and Friends Carers and improving th...

Location

United Kingdom , Aylesbury

Salary:

40109.00 - 47629.00 GBP / Year

Buckinghamshire Council

Expiration Date

July 20, 2026

Requirements

Social work qualification
Active SWE registration
Completed ASYE
Working knowledge of legislation and guidance which applies to family and friends work
Experience of working in looked after children or with foster carers
Knowledge of research, inquiries and recent studies affecting this sector of service and an ability to monitor its application in practice
Strong written communication skills
Minimum of 2 years post qualifying experience
Experience and competence in working with the courts and providing written and verbal evidence

Job Responsibility

Deliver targeted and specialist social work services in the area of Kinship Care
Clarify eligibility and undertake statutory social work assessments
Promote the safety and well-being of children and young people
Assess and support prospective Family and Friends carers in line with Fostering Regulations and court proceedings
Hold a manageable caseload of SG and Reg24 assessments
Provide carer support
Work within statutory guidelines and fostering regulations
Assist with duty with opportunities to deliver training, run support groups and be involved in the organisation of carer events
Support the development and growth of the service

What we offer

Market premium of £2,750 per annum for Grade 7
Golden Hello payment after one years service (£1,000 for Grade 6, £2,125 for Grade 7)
Competitive salary with a market increment
Annual leave up to 30 days per year
Opportunity to buy further leave
Up to 15 days per year training, learning and development offer
Free parking across all office sites
Relocation packages available
Generous employer pension contribution
Discounts on Cafés, restaurants and shops

Fulltime

New

Spanish Speaking Caregiver

Join Our Team as a Caregiver in Lake Ariel, PA! *Earn Up to $14hr + Extra Cash T...

Location

United States , Lake Ariel

Salary:

14.00 USD / Hour

CareGivers America

Expiration Date

Until further notice

Requirements

Must be willing to work in Lake Ariel
Fluent in English, bilingual English/Spanish preferred
Availability to work Wednesday, Thursday, Saturday, and Sunday 6am-6pm
Reliable transportation required
Must be able to travel up to 25 miles to client locations

Job Responsibility

Bring comfort and companionship to clients in their homes
Help with daily care like bathing, dressing, toileting, and meals
Keep living spaces clean, safe, and welcoming
Offer medication reminders and support healthy routines
Communicate concerns and escalate safety issues as needed
Be a friendly face and a steady presence

What we offer

Paid Orientation
Weekly Pay
Flexible Schedules
Earn up to $375 for referring a friend
Caregiver Rewards Program
Premium Holiday Pay
Paid Time Off + Benefits including medical, dental, vision, and retirement
Free Employee Assistance Program
Discount Perks
Career Growth

New

Early Years Consultant

Join our Early Years Service, where we champion the joy of learning for the youn...

Location

United Kingdom , Aylesbury

Salary:

36317.00 - 37780.00 GBP / Year

Buckinghamshire Council

Expiration Date

July 02, 2026

Requirements

Educated to degree level or minimum three years equivalent experience in a similar managerial role
Excellent knowledge and first-hand experience of planning and delivering the EYFS
Experience of supporting vulnerable children including those with SEND and working with their families
Excellent planning and organisational skills
Excellent interpersonal skills
Proven ability to negotiate, inspire and maintain highly effective working relationships
Skilful communicator with ability to engage and influence customers, partners and stakeholders

Job Responsibility

Support providers to deliver the EYFS
Work with providers to meet the needs of all children including those from vulnerable groups and those with SEND
Ensure providers deliver high quality inclusive education
Offer advice and support to ensure early years practitioners deliver an inclusive Early Years Foundation Stage curriculum and meet the requirements of the SEND Code of Practice 2014 and Equality Act 2010
Provide comprehensive support and advice to providers on safeguarding, child protection and the management of allegations against the workforce, along with sustainability, sufficiency, and finance
Contribute to the work of the Early Years Service, ensuring sufficiency of places
Support the early years sector and childcare sector with high quality training, facilitating networking groups and providing advice and support to a full range of Early Years and Childcare providers

What we offer

Fair and inclusive culture
Health and well-being initiatives including Employee Assistance Programme, Mental Health First Aiders and mindfulness workshops
Unified voice through Employee Representative Group
Ongoing support and opportunity to develop and progress in career
Opportunities to take part in fun activities such as fundraising and social events
Flexible and agile working arrangements
Discounts on various cafes, restaurants, shops
Auto enrolment onto generous Pension Scheme
Opportunity to gain membership to Costco
Discounted gym memberships

Fulltime

!

New

Head of Internal Audit

HSBC is one of the largest banking and financial services organizations in the w...

Location

Israel

Salary:

Not provided

HSBC

Expiration Date

August 31, 2027

Requirements

Academic degree (preferable related to finance, accounting or law)
5 years Audit experience
3-5 years experience in the banking industry
Role holder must be located in Israel.
The role requires flexible and adaptable management style.
Fluency in English and Hebrew with strong written and spoken communication skills.
Ability to collaborate with colleagues demonstrating proactive approach.
Knowledge and experience of risk management and controls in financial services.
Knowledge of Internal Audit Frameworks, such as COSO principles and Professional Practice of Internal Auditing, supported by proven experience.
Regulatory acquaintance : Bank of Israel

Job Responsibility

Responsible for the development and implementation of an internal audit strategy in the context of the country and of regulatory requirements, according to regional and global audit policies and methodology.
Devise and implement an Annual Audit Plan which, together with the Regional and Global INA coverage, satisfies the needs of regulators and takes account of key risks in the context of the country.
Initiating and leading the delivery of audits, based on specific regulatory requirements and/or a critical assessment of the business, and the governance, risk and internal control frameworks.
Engaging and collaborating with Global Business, Global Function and Regional Audit Teams and provide strategic advice to them and other internal stakeholders by utilizing knowledge of both the country and the applicable governance, risk and regulatory frameworks.
Managing the interface between internal and external stakeholders to ensure a clear understanding of key deliverables.

What we offer

Tailored professional development opportunities
Competitive pay and benefits package
Welcoming, diverse and inclusive work environment
Industry-leading volunteerism policy
Generous matching gift program
Comprehensive program of immersive Sustainability and Climate Change Initiatives
Employee Resource Groups

Fulltime

New

Caregiver

Join Our Team as a Caregiver in Berks County! *Earn Up to $13.50hr + Extra Cas...

Location

United States , Reading

Salary:

13.50 USD / Hour

CareGivers America

Expiration Date

Until further notice

Requirements

Must be willing to work in Berks County
Must have reliable transportation
Must be willing to travel up to 25 miles to client locations

Job Responsibility

Bring comfort and companionship to clients in their homes
Help with daily care like bathing, dressing, toileting, and meals
Keep living spaces clean, safe, and welcoming
Offer medication reminders and support healthy routines
Communicate concerns and escalate safety issues as needed

What we offer

Paid Orientation
Weekly Pay
Earn up to $375 for referring a friend
Caregiver Rewards Program - Earn extra money for reliability, great care, and MORE
Flexible Schedules — Full-time, part-time, and weekend shifts
Premium Holiday Pay
Paid Time Off + Benefits — Including medical, dental, vision, and retirement
Free Employee Assistance Program — Free support for life, mental health, and well-being
Discount Perks — Save on entertainment, shopping, etc.
Career Growth — build skills and maintain caregiver excellence

New

Social Worker – Under 16s Team

We’re looking for an inspiring, committed and ambitious Social Worker to join ou...

Location

United Kingdom , Aylesbury

Salary:

40109.00 - 47629.00 GBP / Year

Buckinghamshire Council

Expiration Date

July 19, 2026

Requirements

Hold a recognised social work qualification
be registered with Social Work England
full driving licence
enhanced DBS check

Job Responsibility

Carry a varied caseload of children in care and care leavers
undertake assessments
plan and deliver interventions
review progress
work closely with families, carers, and multi‑agency professionals
act as an advocate for their needs
help shape their plans for the future
champion their rights and wellbeing
building meaningful, trusting relationships with children and young people
completing high‑quality assessments and developing child‑centred care and pathway plans

What we offer

Competitive salary with a market increment
Golden Hello payment of £2,125 after 1 years service (Grade 7 external candidates only)
market premium of £2,750 per annum
annual leave up to 30 days per year
opportunity to buy further leave
up to 15 days per year training, learning and development offer
free parking across all of our office sites
relocation packages available

Fulltime

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Sr Associate Regulatory Affairs - CMC

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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