Halocarbon ยท 1 day ago
Regulatory Specialist
North Augusta, SC
Full-time
Onsite
Entry, Mid Level
2+ years expHalocarbon is a company focused on regulatory affairs, and they are seeking a Regulatory Specialist to support the Regulatory Affairs department. The role involves preparing and submitting regulatory documentation, ensuring compliance with regulations, and collaborating with cross-functional teams to facilitate product registrations.
ManufacturingPharmaceutical
Responsibilities
Prepare, review, and submit regulatory documentation for global product registrations, renewals, and updates
Organize regulatory information and track submissions to ensure accuracy and timeliness
Author and/or publish electronic submissions, support annual and periodic reports
Prepare and maintain state and federal licenses, registrations, listings, and establishment documents
Develop technical documentation for EU, Canadian, and Australian submissions
Support drug diversification strategy through preparation of regulatory materials for health authorities
Proofread artwork, labeling components, and SPLs for NDA/ANDA submissions to ensure compliance with RLD labeling
Maintain required regulatory documentation, including SDS, product labels, and EPA and state regulatory files
Review labeling for compliance with regulatory filings and evaluate product changes for regulatory impact
Provide regulatory assessments for pre-approval and post-approval product changes
Ensure compliance with 21 CFR, global regulatory requirements, GMP, and GCP
Assist in implementing new business processes to comply with evolving FDA electronic standards
Interpret global regulations and provide guidance to internal teams
Collaborate with external contractors and internal teams across product development, manufacturing, quality, and marketing
Advise project teams on regulatory requirements, including chemical control laws, export requirements, and compliance issues
Support post-marketing regulatory activities, including review of advertising and promotional materials
Contribute to regulatory strategy development and update strategies in response to regulatory changes
Define and communicate submission and approval requirements, monitor applications under review
Evaluate preclinical, clinical, and manufacturing changes for regulatory filing strategies
Serve as a liaison with regulatory agencies (with oversight) for assigned products
Review and approve critical documents and technical reports for regulatory submission suitability
Identify documentation deficiencies and coordinate with teams to resolve them
Ensure accuracy, completeness, and timely completion of assigned registration activities
Maintain awareness of regulatory trends and assure compliance while minimizing development cycles and costs
Qualification
Required
Bachelor's degree in science or related field is required
Minimum of 2 years of experience in FDA regulatory affairs
Understanding of domestic and international regulatory guidelines, policies and regulations including US FDA, EMA, ICH, USP and other relevant pharmaceutical guidance
Understanding of cGMPs, quality assurance, product stewardship management systems, analytical data, batch records, specifications, and stability studies
Knowledge of DMFs/ASMFs, GDUFA/AGDUFA, Structured Product Labeling (SPL), and annual Drug Experience Reporting (DER)
Knowledge of ANDAs/ANADAs, drug product/substance registrations, and CTD dossiers/modules
Familiarity with Pharmacovigilance and Adverse Event Reporting (ADE)
Effective problem-solving abilities
Effective communication and writing skills
Strong organizational and time management skills
Flexible and able to multi-task
Demonstrated ability to work as part of a team, as well as independently
Base knowledge drug regulations with a desire to expand that knowledge
A consistent track record of competence and effective scheduling coordination
Deep understanding of the regulatory landscape and the ability to navigate complex regulatory processes
Very strong attention to detail and organization
Ability to juggle multiple and competing priorities
Think analytically and critically
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Sound knowledge of a variety of alternatives and their impact on the business
Hands-on, proactive, solution-oriented individual who leads by example and is self-motivated with a high degree of honesty and integrity
Detail orientated, with ability to organize, summarize, and research technical information
Able to interpret and apply toxicological, analytical, and chemical terms / definitions
Research, self-learn, and interface effectively with various government/customer databases/computer systems
Advanced skills in Microsoft Office (Excel, Word, PowerPoint)
Proficient skills in Microsoft Outlook, Teams, OneNote, SharePoint
Strong technical writing skills
Proficient presentation abilities
Excellent organizational skills with a strong work ethic, continuous improvement mentality, and critical thinking abilities
Systems minded and can develop practical product stewardship management systems
Highly capable of working with interdisciplinary teams and respecting people at all levels of the organization
Possess superior interpersonal and communication skills while presenting as thoughtful and considerate
Strong self-awareness with a steady personality, adaptable and reacts positively to change
Must be able to sit and use a computer for extended periods of time
Must be able to climb and descend stairs
Must be able to lift up to 50 lbs
Must maintain a valid drivers license
Must be capable of working in an environment where chemical odors may exist at permissible threshold limits of exposure
Must be able to evacuate the plant, reporting to appropriate assigned muster point, in the event of an emergency or drill
Ability to work autonomously and proactively with supervisory guidance
Ability to lead multiple complex projects to completion with a team
Acts independently on all routine issues, makes judgment and executes
Preferred
2-5 years of experience desired
Additional consideration given to other evidence of certification or on-going professional development
Familiarity with drug product safety reporting, e.g., PSURs, PBRER, PADER is a plus
Manufacturing experience is desirable, with a preference towards pharmaceuticals
Intermediate-Advanced Minitab skills a plus
Company
Halocarbon
Halocarbon is one of the world's leading producers of specialty high-quality fluorochemicals with over 70 years of experience.
51-200 employees
Funding
Current Stage
Growth StageRecent News
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