Regulatory Affairs Specialist

3 weeks ago

Cork, Cork, Ireland SGS Full time
Company Description

SGS is the world's leading Inspection, Verification, Testing and Certification company. We are recognised as the global benchmark for quality and integrity. With more than 99,500 employees, we operate a network of more than 2,500 offices and laboratories around the world. We deliver global service with local expertise, to market leading clients across 10 different industries worldwide.

Our client services include providing SGS Regulatory Affairs and technical support staff on-site to fulfill staffing requirements (Scientific In-sourcing), all under the supervision and guidance of ISL technical and operational teams. Like all SGS personnel, they are committed to upholding stringent technical and GMP standards, ensuring the safety of medications for the multitude of patients relying on the products we test.

Due to growth, we have an exciting opportunity for an experienced Regulatory Affairs Specialist to join our growing Scientific In-sourcing team.

Job Description

What You'll do
  • Preparation and submission of new Marketing Authorisation applications
  • Maintenance of approved marketing authorisation dossiers including submission of variations, renewals and follow-up measures.
  • Preparation of the above submissions in collaboration with other departments and partner companies.
  • Preparation of responses to queries from regulatory authorities and partner companies.
  • Publishing of regulatory submissions using relevant Manager Software.
  • Review and approval of product artworks to ensure compliance with the relevant MA.
  • Interactions with management and partner companies and provision of documentation required to support the MA's they have responsibility for.
  • Regulatory compliance activities and GMP documentation (specifications, batch records etc.).
  • Maintenance of Wholesale Distribution Authorisation.
  • Maintenance of Regulatory forms, logs and databases with up-to-date regulatory information.

GMP
  • Cognisance and compliance with all the necessary elements of process paperwork including Standard Operating Procedures, system logs, stock control systems, machine logs, process documentation and specifications.
  • Responsible at all times for plant and process hygiene within the area of operation.
  • Vigilance for product or process defects and the reporting of same.

Qualifications
  • Level 7 or Bachelors is required.
  • 2 + Years experience in a similar role.
  • Preferably working knowledge of eCTD manager software.
  • To be vigilant when operating machinery and comply with all safety mechanisms.
  • Faulty or unsafe equipment is efficiently reported and rectified.
  • Wearing correct gear and equipment necessary for operation at all times.
  • Co operate with training and screening by the company representing SGS in a professional light.
  • Excellent communication and organisation skills due to the high volumes of documentation.

Additional Information

We offer you:

An opportunity to develop and international career in a friendly, supportive, approachable working environment with a down-to-earth culture. Continuous learning with the chance to expand and enrich your career with our dedicated training team to support your career development opportunities across SGS.
  • An attractive compensation and benefits package including
  • Bonus
  • Healthcare
  • Pension
  • Enhanced annual leave

To apply please submit your CV.

We are an equal opportunity employer and value diversity at our company.
#J-18808-Ljbffr

  • Regulatory Affairs Specialist

    1 hour 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...

  • Medical Device Regulatory Affairs Specialist

    2 weeks ago

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

    ">Regulatory Affairs Specialist">Job Description:">We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will be responsible for ensuring compliance with all relevant regulations and standards.">">Develop and execute regulatory strategies for product registration, approval, and...

  • Regulatory Affairs Strategist

    2 weeks ago

    Cork, Cork, Ireland beBeeRegulatoryStrategist Full time €80,000 - €100,000

    Job OpportunityWe are seeking a seasoned professional to join our team as a Regulatory Affairs Strategist. This individual will play a pivotal role in shaping our global regulatory strategy, ensuring alignment with organizational objectives and effective integration of regulatory considerations into product development.The ideal candidate will possess...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Cork, Cork, Ireland beBeeRegulatory Full time €80,000 - €100,000

    Global Regulatory Associate RoleWe are seeking a highly skilled professional to lead our global regulatory affairs. This role is accountable for the operational and technical registration management processes that support the delivery of safe and effective products to patients.Key ResponsibilitiesProvide Regulatory Expertise: Lead the registration management...

  • Regulatory Affairs Development Role

    5 hours ago

    Cork, Cork, Ireland beBeeRegulatoryAffairs Full time €40,000 - €60,000

    Gain Practical Experience in Regulatory AffairsThis role offers the opportunity to work in a regulated medical device company and develop knowledge of quality, regulatory, and legal frameworks.You will be able to apply basic knowledge of quality, regulatory, and legal processes, procedures, EU Medical Device Directive 93/42/EEC, EU Medical Device Regulation...

  • Cooperative Quality and Regulatory Affairs Specialist

    2 weeks ago

    Cork, Cork, Ireland beBeeQuality Full time €20,000 - €30,000

    Experience a dynamic and challenging environment with this quality and regulatory affairs role. Develop your knowledge of quality systems, regulatory frameworks, and legal requirements to drive improvement in the industry.This position involves collaborating with experienced professionals to identify areas for improvement and develop strategies to address...

  • Regulatory Compliance Professional

    2 weeks ago

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

    Regulatory Affairs SpecialistWe are seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of the Clinical and Regulatory Affairs department, you will play a crucial role in ensuring compliance with regulatory standards and submitting necessary documents to relevant authorities.Your primary responsibility will be to ensure...

  • Regulatory Compliance Specialist

    14 hours ago

    Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €95,000

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Manager to join our organization. This is a permanent role that requires a strong background in either Quality or Regulatory affairs.Main Responsibilities:Develop and implement regulatory strategies to ensure compliance with industry standards.Collaborate with cross-functional teams to resolve...

  • Content Creation Specialist

    2 weeks ago

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

    Labeling and Technical Publication SpecialistThis role involves the creation, revision, and management of labeling documents for medical devices. The successful candidate will work in a world-class environment ensuring that proper information is delivered to customers to enable safe use of our devices.Create labels and technical documentation in compliance...

  • Cmc Regulatory Associate, Gra Regulatory Delivery Excellence

    3 weeks ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...