Title:  Senior Associate, Regulatory Affairs - Labeling

About the Job

Responsible and accountable for maintaining the regulatory aspects of product labelling; 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 labelling support to other associates within the group, as well as within the organization. Requires minimal to no supervision.

Key Responsibilities

• Regular and predictable onsite attendance and punctuality.

• Responsible for the creation, preparation, review, approval and management of pharmaceutical labeling for submission to Health Authorities, including the FDA, based on Reference Listed Drug labeling, Health Authority requirements and company requirements.

• Provides expert support as a regulatory subject matter expert and works 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 Health Authority 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 lablling 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 Health Authorities, including the FDA.

What We Expect

• Bachelor’s Degree required (Science related field)

• Pharmaceutical experience minimum of 6 years of regulatory labeling experience in generic pharmaceuticals

• 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 and other markets, as applicable

• Good understanding of regulations and requirements for US and other markets (as applicable) 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

What We Offer

• A dynamic work environment

• Opportunities to interact with colleagues at all levels, as well as clients and customers

• 30 vacation days per year

• Annual health check-up

• Monthly food and travel allowances