Sr. Manager, Site Reg Affairs

4 weeks ago


Dublin, Dublin City, Ireland Amgen Full time

Group Purpose

To facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Job Summary

The RA CMC Sr. Mgr. supports ADL Site and is responsible for providing guidance and leadership to the ADL Site CMC Team, as needed.

The RA CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity. The CMC site team are members of CMC product teams. The CMC Site team is also responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. The CMC site team is the key RA CMC representative on product deviation investigation teams.

Key Activities

Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements, CMC sections for annual reports and annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams.

Key activities include but are not limited to:

  • Support sites in the execution of change control regulatory assessment and strategy proposal for all markets.
  • Support sites with CTA/MA evaluations and establishment registration submissions.
  • Support sites with variations processes management on special projects.
  • Manage site related CMC processes, policies and best practices.
  • Promotes continuous improvement of processes.
  • Develop and maintain relationships with other functions in development, operations, and commercial to ensure alignment on project/product processes and best practices.
  • Oversee timeline and tracking system information to ensure consistency in planning Site RA CMC deliverables.
  • Serve as an expert advisor to site functional teams, as needed.
  • Support company initiatives and large-scale RA CMC projects as requested.

Knowledge and Skills

RA CMC knowledge and, preferably, experience.

Basic understanding drug development phases.

Ability to develop solutions to technical and/or organizational issues to improve performance and productivity.

Knowledge on Manufacturing and Operations experience desirable.

Ability to work independently.

Basic knowledge on biologics regulations, GMP's, QMS principles with Change control/ Deviations.

Acquainted with electronic QMS systems and RA systems.

Education & Experience (Basic)

Doctorate degree and 2 years of directly related experience OR

Master's degree and 6 years of directly related experience OR

Bachelor's degree and 8 years of directly related experience OR

Associate's degree and 10 years of directly related experience OR

High school diploma / GED and 12 years of directly related experience

Education & Experience (Preferred)

Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry

Regulatory CMC experience



  • Sr. Director

    1 day ago


    Dublin, Dublin City, Ireland eli lilly and company Full time

    Sr. Director - Global Regulatory Scientist - Early Clinical DevelopmentLocation: Ireland, CorkEmployment Type: Full timeAt Lilly, we combine compassion with exploration to enhance the quality of life for individuals worldwide. As a prominent player in the healthcare sector situated in Indianapolis, Indiana, we are dedicated to uncovering and introducing...


  • Dublin, Dublin City, Ireland Microsoft Corporation Full time

    In alignment with our Microsoft values, we are committed to cultivating an inclusive work environment for all employees to positively impact our culture every day. The Datacenter Community Affairs team is part of Microsoft's datacenter organization – Cloud Operations + Innovation (CO+I). It supports the growth and operations of Microsoft's cloud...


  • Dublin, Dublin City, Ireland Amgen Full time

    Job Posting Title Sr Engineer - Drug Process DevelopmentCareer Category Process DevelopmentEmployee Subgroup TBCCountry (State/Region) IrelandLocation (City) Ireland - ADLAmgen Job DescriptionThe Sr Engineer provides process development technical support to large molecule and small molecule drug product manufacturing at ADL as well as part of the global...

  • Advisor/Sr Advisor

    1 day ago


    Dublin, Dublin City, Ireland eli lilly and company Full time

    Advisor/Sr Advisor - PharmacoepidemiologyLocations: Ireland, CorkTime Type: Full-timePosted on: Posted YesterdayJob Requisition ID: R-63073At Lilly, we are a global healthcare leader based in Indianapolis, Indiana. We are dedicated to discovering and providing life-changing medicines, improving disease management, and contributing to communities through...

  • Site Manager

    4 weeks ago


    Dublin, Dublin City, Ireland icds Full time

    Site Manager (infrastructure) Wexford €Neg + transport + package Site Manager required for Largescale civil infrastructure projects in Wexford.Site Management, Coordination & Delivery of onsite activities & management of resources to meet agreed project targets. Implement & deliver project objectives around H&S, Quality, Commercial and Programme. 7+ years'...

  • Site Manager

    3 weeks ago


    Dublin, Dublin City, Ireland ICDS (UK) Ltd Full time

    Site Manager | Limerick, Cork & Munster c.€75K, Car, Bonus, Pension & Benefits. Site Manager for one of Ireland's leading main contractors with high-end developments in Limerick / Muster Area, with decades of experience constructing high end residential (housing & apartments) and commercial developments in very much sought after locations. Offering,...

  • Site Manager

    3 weeks ago


    Dublin, Dublin City, Ireland Vickerstock Full time

    Job Title: Site Manager - RC Structure Experience (St. James, Dublin 8) Company Overview: My client is a leading construction and development firm, and is seeking a seasoned Site Manager with extensive experience in taking projects out of the ground, particularly with reinforced concrete (RC) structures. To play a crucial role in overseeing a landmark...

  • Sr Associate QC

    3 weeks ago


    Dublin, Dublin City, Ireland Amgen Full time

    Job Summary: QC CAS - Sr AssociateUnder minimal supervision, responsible for one or more of the following activities in QC including analytical testing of EU Release, Commercial, Stability, Utilities, raw materials and Validation. Contributes to team by ensuring the quality of the tasks/services provided by self Contributes to the completion of Milestones...

  • Multi-Site Manager

    2 weeks ago


    Dublin, Dublin City, Ireland GrabJobs Full time

    Excel Recruitment are excited to search for a Multi Site Manager for one of our Food Service clients in Galway. We are seeking an experienced Hospitality Professional with a minimum 3 years Site Management experience looking to take the next step in their career.Requirements: Minimum 3 years experience in a busy hospitality environment, preferably with...

  • Fit-Out Site Manager

    3 weeks ago


    Dublin, Dublin City, Ireland CSR Group Full time

    Our client with over 60 years of experience in the Irish Market are growing with a strong pipeline of work in the Dublin area. They are seeking an experienced Fit-Outs Site manager fit -out 8 numbered apartments the project will last 8 months and will ideally suit someone with a trade background. Responsibilities Checking and preparing site reports,...


  • Dublin, Dublin City, Ireland GrabJobs Full time

    Our client is a leading regulatory authority responsible for promoting compliance with consumer protection laws in Ireland. They play a crucial role in enforcing over 40 legislative instruments, including product safety legislation, to enhance consumer welfare and ensure fair and competitive markets. Through various initiatives and campaigns, they aim to...

  • Site Administrator

    2 weeks ago


    Dublin, Dublin City, Ireland ICDS (UK) LTD Full time

    Site Administrator | DublinOur client, a tier- 1 leading main contractor, are currently seeking a Site Administrator in Dublin to oversee two major projects in Tallaght and Leixlip. Key Responsibilities• Efficiently undertake and coordinate all site administration duties on a project, providing admin support to the Contracts Manager and the wider team.•...

  • Site Engineers

    5 days ago


    Dublin, Dublin City, Ireland CSR Group Full time

    Site Engineers - ROI - Multiple Locations The CSR Group has an excellent opportunity for Site Engineers of all levels for projects throughout ROI, namely, Kilkenny, Castleforbes, Dundrum and Rosslare. The company is a top Irish contractor who have secured a number of building and civils projects valued at €5 - 100m, with them there is a clear career path...


  • Dublin, Dublin City, Ireland GrabJobs Full time

    An opportunity to join a huge nationwide company and make your mark, A fantastic time to progress in your career with your expertise to be highly attained and valued with our ongoing and future projects within the midlands. ROLE & RESPONSIBILITIES Plan, and direct activities for the delivery of projects. Develop programmes and manage client and design teams...

  • Site Engineer

    5 days ago


    Dublin, Dublin City, Ireland conrad consulting Full time

    As a Site Engineer, you will play a pivotal role in the successful execution of our modular homes project. You will be responsible for ensuring that all construction activities meet the highest standards of quality and safety. This position is an excellent opportunity for a skilled engineer who is looking to contribute to a transformative project that will...


  • Dublin, Dublin City, Ireland Cpl Full time

    On behalf of my client, a global pharmaceutical company, we are working with them on a new role for a Pharmacovigilance and Clinical Quality Specialist. This is a full-time permanent role based in Dublin. The Role & Responsibilities: The main purpose of this cross functional position is coordinating and leading a variety of: Pharmacovigilance system quality...


  • Dublin, Dublin City, Ireland Cpl Full time

    Medical Advisor/ Medical Science Liaison The Medical Advisor/Medical Science Liaison (MA/MSL) will provide local initiatives, projects and programs along companies Medical Strategy. The MA/MSL will identify and develop relationships with regional and national scientific leaders within the assigned territory will provide clinical and scientific information...


  • Dublin, Dublin City, Ireland Cpl Full time

    Flexsource are currently seeking a Retail Dual Site Manager in Dublin City Center & Blanchardstown About you :• Able to deliver a 'customer first' experience, demonstrating leadership to coach and motivate a team• Able to understand and analyze commercial reports to drive business opportunities• Able to identify key performance behaviors and...

  • Collateral Management

    2 weeks ago


    Dublin, Dublin City, Ireland State Street Full time

    Who we are looking for As a Collateral Management SME, you will interact internally with global Centers of Excellence, Client Middle Office Operations teams and Client operational contacts to complete the collateral management and processing for assigned clients and portfolios. The candidate must exhibit an understanding of Collateral Management Operations...


  • Dublin, Dublin City, Ireland ICDS (UK) Ltd Full time

    Senior Site Engineer | West Dublin/Kildare €80-85k DOE A senior Site Engineer is needed for a new project kicking off in March, 2024, for a new build residential site. The first phase will consist of 200+ units, with phase 2 and 3 to follow. The project is expected to last at least 4/5 years. Requirements: Relevant 3rd level degree in Construction,...