SUMMARY OF POSITION:
The Regulatory Affairs Specialist will be responsible for the support of international product registrations. Specific activities include but are not limited to:
- Maintain up-to-date knowledge of global regulations
- Support worldwide product registrations
- Maintain country specific site registration requirements
- Maintain current regulatory databases to ensure accurate regulatory data
- Collaborate with regional regulatory teams to obtain adequate and accurate registration documents upon fully understanding the local regulations
- Act as liaison between regional regulatory personnel and cross functions to address questions and issues that arise during the registration reviews and/or local product testing
- Maintain and update Samarin database (used for tracking Worldwide Product Registrations)
- Obtaining/Maintaining Certificates of Foreign Government (CFG)/Certificates of Free Sale (CFS)
- Provide regulatory information in support of customer queries, bid and tender submission, etc.
- Understand and recommend registration strategies based on current local regulation and applicable industry standards
- Involve in STED generation and maintenance
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
- Work well independently
- Ability to work collaboratively in a team environment
- Effective oral and written communication skills
- Effective time management skill
- B.S. or B.A. degree required.
- Scientific or engineering field preferred.
- 1-3 years Regulatory Affairs experience or equivalent a must
- Entry level knowledge of U.S. and/or European/International regulations and standards
- 1-2 years’ experience Quality Management system
- Microsoft office (Word, Excel, etc.), Adobe, Access, CECATS, Insight RA tracking system not required benefit.
- Fluent in English required
- Second language desired
The Regulatory Affairs Product Specialist will report into the Regulatory Affairs Product Manager. Interaction with cross-functional personnel at the Engineer and Specialist levels will be frequent. Interaction with management at the Director and Manager levels will be intermittent.
Office setting; very limited travel
METHOD OF VERIFYING COMPETENCE:
Competency will be evaluated through mechanisms such as the annual review process, feedback from internal customers, submission metrics, internal/external audits of the RA function, etc.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.