REGULATORY SPECIALIST Job at Fresenius Kabi
Job Summary
Reports to a Manager, Sr. Manager or Director of Regulatory Affairs. Responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers. Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics. Trains new regulatory specialists. This position has no direct reports.
Responsibilities
The regulatory specialist is responsible for effectively:
- Represent Regulatory Affairs on project teams and providing regulatory guidance
- Clearly and convincingly communicate complex issues
- Share expert knowledge of complex issues
- Review technical documents for cGMP and regulatory compliance
- Prepare and file high-quality submissions to regulatory authorities (A/NDA’s, Supplements, Amendments, Annual Reports and DMF Updates)
- Communicate importance of quality assurance
- Develop regulatory strategy for difficult issues which could significantly impact project timelines and costs
- Provide regulatory decisions with regard to acceptability of submission documents and decisions
- Filing all applications in accordance with predetermined timelines
- Share with others best practices for planning, organization and time management
- Influence and coordinate with external organizations (to RA and/or FK USA) to ensure timelines and project deliverables are met
- Represent FK with regulatory agencies and industry groups as applicable
- Train new regulatory scientists on RA and FK systems
- Work effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
- Dedicate time and energy to remove obstacles to facilitate achievement of team goals
- Ensure that supervisor is aware of activities and progress
- Project professionalism and a courteous, cheerful and cooperative demeanor
- Develop positive internal and external customer relationships
- Other duties as assigned
Job Requirements:
- At minimum, a Bachelor Degree in a scientific discipline and 2-4 years’ experience in pharmaceutical Regulatory Affairs or other scientific area supporting pharmaceutical Regulatory Affairs.
- Experience in preparing and filing complete A/NDA’s, Supplements, Amendments and Annual Reports to FDA
- Thorough understanding of the CFR, FDA/ICH guidelines and cGMP’s, as they pertain to pharmaceuticals
- Well-developed communication skills
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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