Regulatory Specialist

Description:

The Regulatory Specialist is responsible for supporting the Regulatory Affairs department in maintaining efficient and compliant business processes. The Specialist partners with cross-functional teams to gather, organize, and present data required for global product registrations. They prepare, submit, oversee regulatory documentation and ensure accurate information management, file maintenance, and coordination across multiple departments and consultants.

This team member maintains a strong understanding of all aspects of product development, including research, manufacturing practices, regulatory frameworks, and approval processes. They review product promotional materials, labeling, and batch records to ensure compliance with applicable regulations and internal policies. They also advise project teams on premarket and post market regulatory requirements, export and labeling obligations under chemical control laws, and other compliance matters.

This role balances regulatory requirements with technology, marketing objectives, compliance, time to market expectations, and cost considerations. The Specialist works in a fast paced, dynamic environment where effective communication across all organizational levels is essential. They possess a comprehensive understanding of product development and provide guidance on labeling, promotional materials, batch records, and overall regulatory compliance

Key Responsibilities

Regulatory Documentation & Submissions

· 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

Compliance & Regulatory Assessment

· 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

Cross-Functional & Strategic Support

· 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

Quality, Accuracy & Accountability

· 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

Qualifications & Expectations

· Ability to manage multiple simultaneous deadlines with high accuracy

· Strong organizational, communication, and analytical skills

· Commitment to maintaining compliance and supporting business objectives

· Ability to provide daily regulatory support to product development and commercial teams

Requirements:

Education and/or Experience:

· Bachelor’s degree in science or related field is required

· Minimum of 2 years of experience in FDA regulatory affairs, 2-5 years of experience desired

· Additional consideration given to other evidence of certification or on-going professional development

· 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)

· Familiarity with drug product safety reporting, e.g., PSURs, PBRER, PADER is a plus

· Manufacturing experience is desirable, with a preference towards pharmaceuticals

· 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

· This position requires a deep understanding of the regulatory landscape and the ability to navigate complex regulatory processes, and very strong attention to detail and organization

· This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide

· Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various clients and regulatory agencies

· Must be able 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

· Has a sound knowledge of a variety of alternatives and their impact on the business

Analytical Ability/Problem Solving/Technical skills:

· Hands-on, proactive, solution-oriented individual who leads by example and is self-motivated with a high

degree of honesty and integrity

· Must model Halocarbon Values

· 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. Intermediate-Advanced Minitab skills a plus

· 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

Safety/Essential Functions:

· 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

Level of Supervision Needed:

· 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

Autonomy and Supervisory/Lead Responsibility:

· Decisions may require judgement regarding routine activities or regarding standard compliance but also may include strategic or non-programmed decisions based on regulatory knowledge & company policies

*Halocarbon is an equal opportunity employer.