Regulatory Affairs Expert

1 week ago

Cork, Cork, Ireland beBeeRegulatoryAffairs Full time €90,000 - €110,000

**Job Summary**

The CMC Specialist plays a critical role in the global regulatory affairs team, responsible for supporting the completion of Module 1 CMC-related information and regional data for submissions. This includes setting up CMC documents in the regulatory information management system.

**Key Responsibilities:**

  • Develop and utilize information management expertise to support regulatory documentation for all CMC elements of CTD module 1 and regional information.
  • Coordinate global registration activities and request/provide necessary documentation to affiliates for product registration in global countries.
  • Demonstrate an in-depth understanding of content requirements, including awareness of CTD format (module 1).

This position requires a strong understanding of CMC regulatory requirements and ability to manage activities to register new products and renew existing products in global markets.

**Requirements:**

  • Bachelor's Degree in a scientific or health sciences discipline.
  • Knowledge of pharmaceutical drug development or industry-related experience.
  • Ability to operate and manage operational requirements in a regulated environment.

**What We Offer:

A dynamic work environment with opportunities for growth and development.

  • Regulatory Affairs Expert

    1 week ago

    Cork, Cork, Ireland beBeeRegulatory Full time €55,000 - €85,000

    Job Title: Staff Specialist, Regulatory AffairsAbout the Role:As a key member of our regulatory affairs team, you will play a critical role in ensuring our products comply with regulatory requirements.Regulatory Intelligence: Assess and analyze regulatory information to inform local, regional, and global regulatory strategies.Advocacy Activities: Participate...

  • Regulatory Affairs Manager

    2 weeks ago

    Cork, Cork, Ireland Cpl Full time

    Regulatory Affairs Manager – PharmaLocation: Cashel  |  Permanent | Full-TimeAbout The RoleWe are seeking an experienced Regulatory Affairs Manager to join a global pharmaceutical leader. This role offers the opportunity to lead regulatory activities, manage submissions, and develop global regulatory strategies.What You'll DoLead regulatory strategy for...

  • Regulatory Affairs Specialist

    2 weeks ago

    Cork, Cork, Ireland Danaher Life Sciences Full time

    Regulatory Affairs Specialist - 12 month FTC -Maternity CoverJoin to apply for the Regulatory Affairs Specialist - 12 month FTC -Maternity Cover role at Danaher Life SciencesRegulatory Affairs Specialist - 12 month FTC -Maternity Cover1 day ago Be among the first 25 applicantsJoin to apply for the Regulatory Affairs Specialist - 12 month FTC -Maternity Cover...

  • Regulatory Affairs Expert

    2 weeks ago

    Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €80,000

    Job Summary">We are seeking an experienced Regulatory Affairs Professional to join our team. In this role, you will be responsible for regulatory submissions worldwide, annual reporting to notified bodies and competent authorities, and maintaining compliance to standards and regulations.">You will support day-to-day regulatory activities, handle multiple...

  • Regulatory Affairs Professional

    6 days ago

    Cork, Cork, Ireland beBeeRegulatory Full time €65,500 - €98,100

    Regulatory Affairs SpecialistThis is a contract position that offers full benefits. We are seeking a Regulatory Affairs Specialist to join our team.Job Description:Evaluate regulatory data to support the development of local, regional, and global regulatory strategies.Participate in advocacy activities of a technical and/or tactical nature.Analyze the...

  • Regulatory Affairs Professional

    6 days ago

    Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €90,000

    Regulatory Affairs SpecialistThe role of Regulatory Affairs Specialist plays a vital part in ensuring compliance with regulatory requirements.Main Responsibilities:Evaluating the regulatory environment and providing advice throughout the product lifecycle to ensure product compliance.Assessing regulatory intelligence to develop global regulatory...

  • Regulatory Affairs Manager

    1 week ago

    Cork, Cork, Ireland Cpl Full time

    Regulatory Affairs Manager – PharmaLocation: CashelEmployment type: Permanent | Full-TimeAbout The RoleWe are seeking an experienced Regulatory Affairs Manager to join a global pharmaceutical leader. This role offers the opportunity to lead regulatory activities, manage submissions, and develop global regulatory strategies.What You'll DoLead regulatory...

  • Regulatory Affairs Specialist

    2 weeks ago

    Cork, Cork, Ireland beBeeSpecialist Full time €70,000 - €104,000

    Regulatory Affairs Specialist JobWe are seeking a skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Assess regulatory intelligence to inform the development of local, regional, and global regulatory strategies.Participate in advocacy activities of a technical and/or tactical nature.Evaluate the regulatory environment and provide...

  • Global Regulatory Affairs Director

    3 days ago

    Cork, Cork, Ireland beBeeDirector Full time €100,000 - €120,000

    Job Title: Global Regulatory Affairs DirectorThis position plays a crucial role in leading the global labeling strategy for pharmaceuticals, ensuring timely delivery of core labeling documents and collaboration with cross-functional teams.Key Responsibilities:Develop and implement a comprehensive global labeling strategy to facilitate simultaneous global...

  • Regulatory Affairs Specialist

    4 days ago

    Cork, Cork, Ireland beBeeRegulatoryAffairs Full time €70,000 - €90,000

    Job Title: Regulatory Affairs SpecialistJob DescriptionThe position of Senior Regulatory Affairs Specialist entails overseeing activities related to maintaining and obtaining regulatory approval for medical devices. This includes evaluating the implications of device changes, developing comprehensive regulatory strategies for US, EU, and international...