McKesson Regulatory Affairs Specialist in Munster, Ireland

NorthStar Rx LLC ("NorthStar", a business of McKesson) supplies high quality generic pharmaceuticals. NorthStar products are manufactured at established facilities that are registered with the U.S. Food and Drug Administration (FDA). We manufacture generic drugs in an efficient and cost-effective manner to generate increased savings for you.

McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payors, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. We believe in the importance of strong, vital organizations because we know that patients can only be healthy when our system is healthy.

Every single McKesson employee contributes to our mission—by joining McKesson you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.

We understand the importance of a system that works together. Your expertise, drive and passion can help us improve everything we touch, from providers to payors to pharmacies. Join our team of leaders to begin a rewarding career.

Wherever you contribute here at McKesson, you will have the ability to make a real impact in the lives of others.

Position: Regulatory Affairs Specialist

Reporting to the Regulatory Affairs Manager the post holder will have responsibility for monitoring regulatory compliance across multiple territories. The key function of this role is to minimize the risk to NorthStar by ensuring a high level of regulatory compliance, supporting regulatory submissions, ensuring product safety and labelling compliance.

The post holder will assist in the monitoring of multiple global suppliers to ensure regulatory compliance, generate metrics and prepare reports for the regulatory department.

KEYRESPONSIBILITIES

  • PerformRegulatory Affairs activities ensuring compliance with applicableregulations and requirements, including but not limited to

Oversee and contribute to the preparation of regulatory submissions


Manage submission timelines, monitor approval status and communicate change status to concerned parties in a timely manner


Prepare, review and/or approval of regulatory change controls, risk assessments


Respond to Competent Authorities’ queries and deficiencies in a timely manner

  • Maintaina good understanding of existing and emerging pharmaceutical regulationsand provide regulatory direction and support

  • Monitorand interpret new and existing regulations and guidance’s to evaluate theimpact on the NorthStar business

  • Liaiseeffectively with internal departments and external suppliers to supportthe timely introduction of new products to market

  • Ensurecompliant operation and maintenance of internal processes and systems foraccuracy of content

  • Ensurethe effective implementation of a quality management system in theRegulatory function

  • Workas a team member in developing the regulatory oversight of suppliers

  • Preparationof monthly metrics and reports to monitor and cross-compare the qualitysystems

  • Participatein regular team and group meetings ensuring to keep the management teamupdated on issues and actions which impact the business

  • Be flexible within the Regulatory function to meet theneeds of the growing business; using technical expertise, skills, knowledgeand experience

  • Support cross-training opportunities and skills

  • Provide day-to-day department support activities as necessaryto aide completion of project deliverables

  • Performgeneral duties as required by the Regulatory Manager

Education/Training:

Educated to degree level or higher in Chemistry, Microbiology or other scientific discipline

Experience:

5 years FDA regulated pharmaceutical experience; 2-3 years regulatory affairs experience

Knowledge andSkills:

· Thorough understanding of regulatory and compliance guidelines within pharmaceutical manufacturing

· An understanding of relevant directives, standards, policies and guidelines and the ability to implement appropriately

· Excellent interpersonal skills, self-motivation and sense of urgency to complete assignments on time

· Excellent communication skills with ability to communicate at all levels within the organization

· Ability to work independently and make decisions based on judgement and integrity

· Proven analytical and problem solving skills and the ability to transfer findings into report and presentation formats

· Ability to work effectively with others to accomplish goals in a challenging environment

· Excellent organisational and time management skills

· Understanding of customs and beliefs of other groups or cultures

· Familiarity with concepts of Regulatory Approval process for generic pharmaceutical products an advantage

Job: Distribution Operations

Organization: McKesson Corporate

Title: Regulatory Affairs Specialist

Location: Ireland-Munster-Cork

Requisition ID: 17004993