Overview

INTERN Job at Northstar Healthcare Unlimited – in Cork, County Cork

Job Description

The Regulatory Affairs Co-Op Student will play a key role in supporting the team achieve its business goals. Northstar will support this individual during their internship to develop key experience and skills to support them in their future career development. Supporting the broader organisation, the individual will interact with NorthStar personnel in London and Memphis offices as well as with the personnel within the additional McKesson private labels that NorthStar supports. The role involves provision of support in various elements of compliance across new product introductions including regulatory, labeling and pharmacovigilance activities. The role will involve day to day support of various regulatory and quality processes, procedures and administrative functions.



KEY RESPONSIBILITIES

  • Assist team members to liaise effectively with internal departments and external suppliers to support the timely introduction of new products to the US market. Support the launch a product in the US by being involved in all pre-commercial regulatory activities, including issuance of unique NDC and UPC codes, label review and product registrations.
  • Supporting Pharmacovigilance obligations by o Inputting and maintaining adverse event records in NorthStar’s electronic Quality Management System (eQMS), Master Control, ensuring records are accurate and current.

o Support the maintenance of Safety Data Exchange Agreements and management within NorthStar’s eQMS.

o Perform general pharmacovigilance activities to support compliance to contractual obligations

  • Assist in product labeling life cycle management including o Monitoring labeling updates for impact to NorthStar artwork

o Monitoring of FDA registrations and compiling FDB registration packages.

o Supporting onboarding suppliers on the operation of NorthStar’s artwork management system, Opal.

o Maintaining records of artwork status and supporting documentation

  • Perform general regulatory activities to facilitate to the maintenance of the NorthStar filings and to support suppliers in maintaining their regulatory filings.
  • Co-ordinate a project to support compliance to Consumer Product Safety Commission requirements
  • Participate in the preparation of supplier scorecards and site metrics
  • Assist in the drafting and management of quality documents, such as Stand Operating Procedures
  • Provide operational support to team members by assisting with ad hoc regulatory support activities as required.

(The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned, as required, by management.)

About the Company

Company: Northstar Healthcare Unlimited –

Company Location:  Cork, County Cork

Estimated Salary:

About Northstar Healthcare Unlimited -