Sr. Specialist, Regulatory Affairs - Labeling

Hikma Pharmaceuticals USA Inc.•Columbus, OH

6h•Onsite

About The Position

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 DailyMed. 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.

Requirements

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 labelling 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 the ability to ensure high quality labeling is generated and maintained.

Nice To Haves

6+ year experience in pharmaceutical industry.

Responsibilities

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 labelling in SPL and PLR format, and maintenance of all labelling 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 DailyMed.
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.

Benefits

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave