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.
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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.
- 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
Educated to degree level or higher in Chemistry, Microbiology or other scientific discipline
5 years FDA regulated pharmaceutical experience; 2-3 years regulatory affairs experience
· 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
Requisition ID: 17004993