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Regulatory Affairs Scientist

Title : Regulatory Affairs Scientist profile
Sector : Scientific & Laboratory
Location : Cork
Reference : CW120455
Contact : Conor Twomey
Office : Shannon
Tel : +353 21 4297422
Email : ctwomey@careerwise.ie

Job Description

REGULATORY AFFAIRS SCIENTIST required by CareerWise Recruitment for multinational Pharmaceutical client in Co. Cork. The REGULATORY AFFAIRS SCIENTIST will oversee the preparation and documentation of specified regulatory submissions and provide regulatory leadership and direction for products listed as primary responsibilities.

Role of this position

  • 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 Lilly’s international Manufacturing Site Regulatory Group to share best practices and develop internal guidelines/initiatives
  • Will participate, where applicable, in industry association meetings (e.g. PCI) and Lilly groups to benchmark and influence revisions to guidance’s
  • 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 Provides comments on draft guidance’s, as applicable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.

JOB REQUIREMENTS

  • Minimum of degree, ideally an advanced degree (MS or PhD preferred), in related biological and life science field
  • 5+ years relevant regulatory affairs experience in the pharmaceutical/bio-pharmaceutical industry.
  • Substantial post-qualification experience in either a pharmaceutical or biotech setting, previous experience with regulatory submissions is an advantage.
  • Strong knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing.
  • 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.

Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999 CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.


 

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Careerwise Recruitment



Regulatory Affairs Scientist

Title : Regulatory Affairs Scientist profile
Sector : Scientific & Laboratory
Location : Cork
Reference : CW120455
Contact : Conor Twomey
Office : Shannon
Tel : +353 21 4297422
Email : ctwomey@careerwise.ie

Job Description

REGULATORY AFFAIRS SCIENTIST required by CareerWise Recruitment for multinational Pharmaceutical client in Co. Cork. The REGULATORY AFFAIRS SCIENTIST will oversee the preparation and documentation of specified regulatory submissions and provide regulatory leadership and direction for products listed as primary responsibilities.

Role of this position

  • 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 Lilly’s international Manufacturing Site Regulatory Group to share best practices and develop internal guidelines/initiatives
  • Will participate, where applicable, in industry association meetings (e.g. PCI) and Lilly groups to benchmark and influence revisions to guidance’s
  • 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.

JOB REQUIREMENTS

  • Minimum of degree, ideally an advanced degree (MS or PhD preferred), in related biological and life science field
  • 5+ years relevant regulatory affairs experience in the pharmaceutical/bio-pharmaceutical industry.
  • Substantial post-qualification experience in either a pharmaceutical or biotech setting, previous experience with regulatory submissions is an advantage.
  • Strong knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing.
  • 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.

Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999 CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.


 

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