CareerWise Recruitment

Principal Scientist - Global RA (CMC)

View CareerWise Recruitment profile
Location
Limerick, Co. Limerick
Location type
At the office
Employment type
Full time
Job type
Permanent
Apply now
Apply now

A Principal Scientist: Global Regulatory Affairs (CMC) is required on a PERMANENT basis by CareerWise Recruitment for our Limerick based start-up Biopharmaceutical Client.

The purpose of the role is to provide strategic, tactical and operational direction to expedite CMC development of Client portfolio and technical agenda by supporting global clinical trial, market registration submissions and post-approval submissions. These activities are accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes. To accomplish this purpose, it is necessary for the Regulatory Scientist to develop collegial and mutually productive relationships and by a demonstrated ability to establish and/or to promote / refine key regulatory CMC positions and to effectively influence development, manufacturing and GRA leadership on these positions.

THE ROLE:

  • Will oversee the preparation and documentation of specified regulatory submissions
  • Provide regulatory leadership and direction for products listed as primary responsibilities
  • Will develop, plan and execute appropriate regulatory strategies and priorities through effective partnership with other departments such as TS/MS (process and technology transfer), manufacturing, quality control and quality assurance
  • Manage submission timelines, monitor approval status and communicate change status to interested personnel in a timely manner
  • Will have a good understanding of existing and emerging pharmaceutical & biotech-related regulations
  • Provides the necessary CM&C commitment information to site personnel
  • Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)
  • Review and/or approval of regulatory changes, regulatory deviations, proposals for reprocessing, validation and stability protocols
  • Will participate in Global Regulatory Affairs-CMC group to share best practices and develop internal guidelines/initiatives
  • Will participate, where applicable, in industry association meetings (e.g. PCI) and Client groups to benchmark and influence revisions to guidance
  • Will interpret new/revised guidance documents and evaluates impact for site. Provides comments on draft guidance’s, as applicable
  • Will provide training to site personnel regarding product registration requirements and applicable regulations and guidelines

REQUIREMENTS:

  • Level 8 Bachelor's degree in sciences discipline (e.g. chemistry, biology, biochemistry or pharmacy or related scientific discipline) required.
  • Prior Regulatory CMC experience (3-7 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.
  • Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered.
  • Strong knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing
  • Good attention to detail and demonstrated effective teamwork skills
  • Proven ability to effectively influence within and beyond the organization
  • Can demonstrate leadership capabilities, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective.
  • Will facilitate a collaborative environment with all internal and external stakeholders.
  • Stay abreast with current technical and regulatory trends and continually develop knowledge by attending training courses, conferences or association meetings and share such information with other members of the group or company to increase their awareness.
  • Lead and/or contribute corporate improvement efforts at local and international level.


Please call Aisling O’Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

Important Dates
Posted on
21 May, 2024
Application deadline
20 June, 2024
Reference number
JOB-15930

Jobs at CareerWise Recruitment

View all CareerWise Recruitment jobs
CareerWise Recruitment

EHS & Occupational Hygiene Specialist

County Cork, Co. Cork
Full time
10 hours ago
CareerWise Recruitment

Automation Engineer

Full time
€75,000 - 85,000
1 day ago
CareerWise Recruitment

Associate Director - FP&A

Cork, Co. Cork
Full time
1 day ago
CareerWise Recruitment

Validation Microbiologist

Galway, Co. Galway
Full time
2 days ago

Related Jobs

CPL

Principal Scientist- Global Regulatory Affairs

Limerick, Co. Limerick
Full time
Negotiable
3 weeks ago
CareerWise Recruitment

HR Generalist

Shannon, Co. Clare
Full time
2 weeks ago
CareerWise Recruitment

QA Specialist

County Clare, Co. Clare
Full time
3 weeks ago
CareerWise Recruitment

Senior Process Engineer

Full time
€80,000 - 100,000
1 week ago