Sr. Specialist, Regulatory Affairs - Labeling; onsite

Job Title

Sr. Specialist, Regulatory Affairs - Labeling

Columbus, OH

Full time

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Specialist, Regulatory Affairs - Labeling to join our team.

In this role, you will be responsible and accountable for maintaining the regulatory aspects of product labeling; draft new and revise existing artwork for pre-approval, lifecycle maintenance products, and 3rd party customers/partners. Responsible for managing Drug Listings and ensuring accuracy of Daily Med. The candidate will be responsible for providing expert support in applicable team meetings and when consulted and operate as a SME regarding regulatory labeling guidances/regulations and strategies to other members of the regulatory department, as well as to other departments.

The candidate will be expected to mentor and provide regulatory labeling support to other associates within the group, as well as within the organization. Requires minimal to no supervision.

• Regular and predictable onsite attendance and punctuality.
• Responsible for the creation, preparation, review, approval and management of pharmaceutical labeling for submission to US FDA based on Reference Listed Drug labeling, FDA requirements and company requirements.
• Provides expert support as a regulatory subject matter expert and work closely with cross-functional departments to provide the appropriate regulatory requirements/guidance.
• Responsible for the creation of labeling in SPL and PLR format, and maintenance of all labeling files in accordance with internal procedures.
• Responsible for identifying changes needed for FDA approved labeling including updates to Reference Listed Drug, USP updates and updates for new regulatory requirements.
• Responsible for the product registrations and maintenance of product drug listings, and accuracy of labeling posted to Daily Med.
• Stays current with emerging regulatory labeling guidance, and industry expectations and standards, and demonstrates the ability to translate these into process improvements or best practices.
• Actively looks for ways to improve current processes within department and across the business to gain efficiency and quality labeling submissions to US FDA.

• High School Diploma or GED and 6+ years of regulatory labeling experience in highly regulated industry.
• Bachelor’s degree in scientific discipline and 6+ years of regulatory labeling experience in highly regulated industry; experience in pharmaceutical industry highly desired.
• Excellent verbal and written communication skills with all levels of the organization.
• Ability to multitask and manage timelines and priorities with minimal to no supervision.
• Ability to work independently with minimal to no guidance with good judgement and decision-making skills.
• Ability to organize, plan, and prioritize workload to accomplish goals and objectives with minimal supervision.
• Excellent attention to detail.
• Critical Thinking.
• Thorough understanding and expert knowledge of regulatory requirements for pre-approval and post-approval labeling submissions for the US Market.
• Good understanding of regulations and requirements for US market through expert knowledge, FDA Guidance Documents and MAPPs, ICH Guidelines, Code of Federal Regulations as they pertain to generic drug product labeling.
• Demonstrates…