Regulatory Affairs Intern

at  McKesson

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.
What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.

Based in Cork, Ireland, NorthStar Healthcare is a leading international supplier of generic pharmaceutical drugs and a wholly owned subsidiary of McKesson Corporation. NorthStar products are manufactured at established facilities that are registered with the U.S. Food and Drug Administration (FDA). NorthStar manufacture generic drugs in an efficient and cost-effective manner to generate increased savings for its diverse customer base in North America. NorthStar customers include:

• Independent Retail Pharmacy Owners across North America
• Hospitals
• Long-Term Care Pharmacies
• National Retail Chains in North America
• McKesson Owned Pharmacies in North America and Europe.

The NorthStar generics portfolio is broad and continues to meet the wide-ranging, ever-growing needs of its customers. Since launching its first drug in September 2007, NorthStar have grown to become a significant growth driver for McKesson and its global sourcing strategy.
In 2020, NorthStar assumed responsibility for the Regulatory and Quality compliance for additional McKesson private Labels, McKesson Corporation dba SKY Packaging and Strategic Sourcing Services LLC.

KNOWLEDGE AND SKILLS

• Excellent Interpersonal and Communication skills.
• Ability to work collaboratively as part of the Regulatory Affairs and wider business team.
• Multi-tasking and time Management skills and flexible to change work direction as needed.
• Enthusiasm and willingness to learn.
• Excellent attention to detail.
• Good administration skills, organized with prioritization skills.
• Proficient in MS Office and willing to learn new systems.
• Demonstrate energy and enthusiasm in personal interactions.

THE ROLE:

The Regulatory Affairs and Quality Compliance Co-Op student will play a key role in supporting the team achieve its business goals. NorthStar will support this individual during their internship so that they develop key skills and experience to support them in their future career development. Supporting the broader organization, 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 quality compliance 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.
• Co-ordinate an internal project to support regulatory and/or quality compliance
• Supporting Pharmacovigilance obligations by
• Support the maintenance of Safety Data Exchange Agreements and management within NorthStar’s eQMS.
• Support the management of pharmacovigilance audit reports within NorthStar’s eQMS.
• Perform general pharmacovigilance activities to support compliance to contractual obligations
• Assist in product labelling life cycle management including:
• Monitoring labelling updates for impact to NorthStar artwork
• Monitoring of FDA registrations and compiling FDB registration packages.
• Supporting onboarding suppliers on the operation of NorthStar’s artwork management system, Opal.
• 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 TAA (Trade Agreement Act)
• 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 and quality compliance support activities as required.