CrawlJobs Logo
Amgen Logo Amgen · IT - Administration

Sr Associate Regulatory Affairs - CMC

United Kingdom, Uxbridge Employment contract · Job Posted June 10, 2026
Apply Position
Job Link Share

Job Description

If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

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

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

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
Amgen - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Sr Associate Regulatory Affairs - CMC

8 matching positions

Sr Associate, Manufacturing Regulatory

The Sr Associate, Manufacturing Regulatory Affairs is responsible for supporting...
Location
Location
Italy , Pomezia
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • competitive salary
  • comprehensive benefits
  • extensive opportunities for professional growth and development
  • Fulltime
Read More
Arrow Right
New

Staff Pharmacist

We’re building a world of health around every individual — shaping a more connec...
Location
Location
United States , Newport News
Salary
Salary:
60.00 - 76.00 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
August 08, 2026
Flip Icon
Requirements
Requirements
  • Active Pharmacist License in the state where the Store is located
  • Active National Provider Identifier (NPI)
  • Not on the DEA Excluded Parties list
Job Responsibility
Job Responsibility
  • Living our purpose by helping to manage and improve patient health through safe and appropriate dispensing, counseling, and immunizing practices
  • Taking direction from the Pharmacy Manager and overseeing the pharmacy as their proxy during bench shifts without overlap, including strengthening pharmacy performance measures through effective coaching and consistent follow-up of pharmacy team members and providing feedback about pharmacy team performance to the Pharmacy Manager as needed
  • Assumes Pharmacy Manager’s day-to-day duties when serving as the only or the primary pharmacist-on-duty
  • Supporting safe and accurate prescription fulfillment by following—and directing the pharmacy team to follow—pharmacy workflow procedures and utilizing the safety guardrails at every workstation
  • Contributing to positive patient experiences by showing empathy and genuine care, and coaching the pharmacy team to do the same: demonstrating compassionate care, collaborating with the patient’s total healthcare team, and proactively resolving insurance and/or medication issues
  • Proactively offering and delivering immunizations to keep patients healthy
  • engaging and supporting Pharmacy Technicians to learn to immunize
  • Supporting the effective management of pharmacy inventory by following—and coaching the pharmacy team to follow—all inventory best practices, with a special focus on protecting cold chain products for our patients and our business
  • Partnering with the Pharmacy Manager to ensure pharmacy operations are compliant with the appropriate state Board of Pharmacy regulations at all times
  • escalating issues or concerns to the Pharmacy Manager and/or Rx DL for timely resolution if/as needed
What we offer
What we offer
  • medical, dental, and vision coverage
  • paid time off
  • retirement savings options
  • wellness programs
  • Fulltime
Read More
Arrow Right
New

Staff Pharmacist

We're building a world of health around every individual — shaping a more connec...
Location
Location
United States , Arlington
Salary
Salary:
60.00 - 76.00 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
August 09, 2026
Flip Icon
Requirements
Requirements
  • Active Pharmacist License in the state where the Store is located
  • Active National Provider Identifier (NPI)
  • Not on the DEA Excluded Parties list
  • Regular and predictable attendance, including nights and weekends
  • Ability to complete required training within designated timeframe
  • Attention and Focus: Ability to concentrate on a task over a period of time
  • Ability to pivot quickly from one task to another to meet patient and business needs
  • Ability to confirm prescription information and label accuracy, ensuring patient safety
  • Customer Service and Team Orientation: Actively look for ways to help people, and do so in a friendly manner
  • Notice and understand patients' reactions, and respond appropriately
Job Responsibility
Job Responsibility
  • Living our purpose by helping to manage and improve patient health through safe and appropriate dispensing, counseling, and immunizing practices
  • Taking direction from the Pharmacy Manager and overseeing the pharmacy as their proxy during bench shifts without overlap, including strengthening pharmacy performance measures through effective coaching and consistent follow-up of pharmacy team members and providing feedback about pharmacy team performance to the Pharmacy Manager as needed
  • Assumes Pharmacy Manager's day-to-day duties when serving as the only or the primary pharmacist-on-duty
  • Supporting safe and accurate prescription fulfillment by following—and directing the pharmacy team to follow—pharmacy workflow procedures and utilizing the safety guardrails at every workstation
  • Contributing to positive patient experiences by showing empathy and genuine care, and coaching the pharmacy team to do the same: demonstrating compassionate care, collaborating with the patient's total healthcare team, and proactively resolving insurance and/or medication issues
  • Proactively offering and delivering immunizations to keep patients healthy
  • engaging and supporting Pharmacy Technicians to learn to immunize
  • Supporting the effective management of pharmacy inventory by following—and coaching the pharmacy team to follow—all inventory best practices, with a special focus on protecting cold chain products for our patients and our business
  • Partnering with the Pharmacy Manager to ensure pharmacy operations are compliant with the appropriate state Board of Pharmacy regulations at all times
  • escalating issues or concerns to the Pharmacy Manager and/or Rx DL for timely resolution if/as needed
What we offer
What we offer
  • medical
  • dental
  • vision coverage
  • paid time off
  • retirement savings options
  • wellness programs
  • bonus, commission or short-term incentive program
  • Fulltime
Read More
Arrow Right
New

Pharmacy Technician

We're building a world of health around every individual — shaping a more connec...
Location
Location
United States , Tucson
Salary
Salary:
17.45 - 27.45 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
August 09, 2026
Flip Icon
Requirements
Requirements
  • Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
  • If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
  • If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
  • State-level licensure and national certification requirements vary by state
Job Responsibility
Job Responsibility
  • Living our purpose by following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
  • Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
  • Contributing to positive patient experiences by showing empathy and genuine care: creating heartfelt and personalized moments while serving patients at pick-up, drive-thru, and over the phone
  • keeping patients healthy by offering immunizations and other services at the register and over the phone
  • and demonstrating compassionate care by solving or escalating patient problems
  • Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team, such as accurately putting away medication deliveries and completing cycle counts, returns-to-stocks, waiting bin inventories, etc.
  • Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback
  • actively seeking opportunities to expand clinical and technical knowledge needed to better assist patients
  • Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
  • voluntarily traveling to stores in the market to work shifts as needed by the business
What we offer
What we offer
  • dental
  • vision
  • wellness resources
  • employee discounts
  • access to certain voluntary benefits
  • other programs
  • Parttime
Read More
Arrow Right
New

Web Designer (UI/UX)

Location
Location
Japan , 東京23区
Salary
Salary:
5000000.00 - 7000000.00 JPY / Year
https://www.randstad.com Logo
Randstad
Expiration Date
June 04, 2027
Flip Icon
Requirements
Requirements
  • Basic knowledge of design and at least 3 years of work experience
  • Adobe Creative Suite (Photoshop, Illustrator, XD, etc.) skills
  • Skills in Figma, Sketch, etc.
  • Coding skills in HTML, CSS and JavaScript ability to submit a portfolio of work
  • Communication and teamwork skills
  • Creativity and willingness to propose new ideas
  • Able to always be conscious of improving operational efficiency
Job Responsibility
Job Responsibility
  • International Environment
  • Free Meals
What we offer
What we offer
  • 健康保険
  • 厚生年金保険
  • 雇用保険
  • 日曜日,土曜日,祝日
  • Fulltime
Read More
Arrow Right
New

Night Pharmacist FT

We’re building a world of health around every individual — shaping a more connec...
Location
Location
United States , Rio Rancho
Salary
Salary:
60.00 - 76.00 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
December 20, 2026
Flip Icon
Requirements
Requirements
  • Active Pharmacist License in the state where the Store is located
  • Active National Provider Identifier (NPI)
  • Not on the DEA Excluded Parties list
Job Responsibility
Job Responsibility
  • Living our purpose by helping to manage and improve patient health through safe and appropriate dispensing, counseling, and immunizing practices
  • Taking direction from the Pharmacy Manager and overseeing the pharmacy as their proxy during bench shifts without overlap, including strengthening pharmacy performance measures through effective coaching and consistent follow-up of pharmacy team members and providing feedback about pharmacy team performance to the Pharmacy Manager as needed
  • Assumes Pharmacy Manager’s day-to-day duties when serving as the only or the primary pharmacist-on-duty
  • Supporting safe and accurate prescription fulfillment by following—and directing the pharmacy team to follow—pharmacy workflow procedures and utilizing the safety guardrails at every workstation
  • Contributing to positive patient experiences by showing empathy and genuine care, and coaching the pharmacy team to do the same: demonstrating compassionate care, collaborating with the patient’s total healthcare team, and proactively resolving insurance and/or medication issues
  • Proactively offering and delivering immunizations to keep patients healthy
  • engaging and supporting Pharmacy Technicians to learn to immunize
  • Supporting the effective management of pharmacy inventory by following—and coaching the pharmacy team to follow—all inventory best practices, with a special focus on protecting cold chain products for our patients and our business
  • Partnering with the Pharmacy Manager to ensure pharmacy operations are compliant with the appropriate state Board of Pharmacy regulations at all times
  • escalating issues or concerns to the Pharmacy Manager and/or Rx DL for timely resolution if/as needed
What we offer
What we offer
  • medical, dental, and vision coverage
  • paid time off
  • retirement savings options
  • wellness programs
  • bonus, commission or short-term incentive program
  • Fulltime
Read More
Arrow Right
New

District Support Pharmacist

We’re building a world of health around every individual — shaping a more connec...
Location
Location
United States , Worcester
Salary
Salary:
60.00 - 76.00 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
August 09, 2026
Flip Icon
Requirements
Requirements
  • Active Pharmacist License in the state where the Store is located
  • Active National Provider Identifier (NPI)
  • Not on the DEA Excluded Parties list
  • Ability to travel within a reasonable radius to support market staffing as business needs require
  • Regular and predictable attendance, including nights and weekends
  • Ability to complete required training within designated timeframe
  • Attention and Focus: Ability to concentrate on a task over a period of time
  • Ability to pivot quickly from one task to another to meet patient and business needs
  • Ability to confirm prescription information and label accuracy, ensuring patient safety
  • Customer Service and Team Orientation: Actively look for ways to help people, and do so in a friendly manner
Job Responsibility
Job Responsibility
  • Living our purpose by helping to manage and improve patient health through safe and appropriate dispensing, counseling, and immunizing practices
  • Traveling the district to fill pharmacist shifts as scheduled by the District Performance Coordinator (DPC)
  • overseeing the pharmacy and serving as the Pharmacy Manager’s proxy during bench shifts without overlap
  • Supporting safe and accurate prescription fulfillment by following—and directing the pharmacy team to follow—pharmacy workflow procedures and utilizing the safety guardrails at every workstation
  • Assumes Pharmacy Manager’s day-to-day duties when serving as the only or the primary pharmacist-on-duty
  • Contributing to positive patient experiences by showing empathy and genuine care and coaching the pharmacy team to do the same: demonstrating compassionate care, collaborating with the patient’s total healthcare team, and proactively resolving insurance and/or medication issues
  • Proactively offering and delivering immunizations to keep patients healthy
  • engaging and supporting Pharmacy Technicians to learn to immunize
  • Supporting the effective management of pharmacy inventory in all pharmacies worked by following—and guiding the pharmacy team to follow—all inventory best practices, with a special focus on protecting cold chain products for our patients and our business
  • Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
What we offer
What we offer
  • medical, dental, and vision coverage
  • paid time off
  • retirement savings options
  • wellness programs
  • other resources, based on eligibility
  • Fulltime
Read More
Arrow Right
New

District Support Pharmacist

We’re building a world of health around every individual — shaping a more connec...
Location
Location
United States , Versailles
Salary
Salary:
60.00 - 76.00 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
August 07, 2026
Flip Icon
Requirements
Requirements
  • Active Pharmacist License in the state where the Store is located
  • Active National Provider Identifier (NPI)
  • Not on the DEA Excluded Parties list
Job Responsibility
Job Responsibility
  • Helping to manage and improve patient health through safe and appropriate dispensing, counseling, and immunizing practices
  • Traveling the district to fill pharmacist shifts as scheduled by the District Performance Coordinator (DPC)
  • overseeing the pharmacy and serving as the Pharmacy Manager's proxy during bench shifts without overlap
  • Supporting safe and accurate prescription fulfillment by following—and directing the pharmacy team to follow—pharmacy workflow procedures and utilizing the safety guardrails at every workstation
  • Assumes Pharmacy Manager's day-to-day duties when serving as the only or the primary pharmacist-on-duty
  • Contributing to positive patient experiences by showing empathy and genuine care and coaching the pharmacy team to do the same
  • Proactively offering and delivering immunizations to keep patients healthy
  • engaging and supporting Pharmacy Technicians to learn to immunize
  • Supporting the effective management of pharmacy inventory in all pharmacies worked by following—and guiding the pharmacy team to follow—all inventory best practices
  • Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
What we offer
What we offer
  • Medical coverage
  • Dental coverage
  • Vision coverage
  • Paid time off
  • Retirement savings options
  • Wellness programs
  • Bonus, commission or short-term incentive program
  • Fulltime
Read More
Arrow Right