Regulatory Labeling Specialist Jobs

Complete all other duties as assigned by management.

Strong interpersonal and communications skills and organizational and planning abilities needed to handle multiple tasks concurrently.

Research of International, Federal, State, local, and internal regulatory requirements

Maintain working knowledge and understanding of existing and emerging food and dietary supplement regulations.

Assisting with obtaining, and/or renewing relevant national certifications.

Work closely with the Quality Manager and Product Development teams to ensure compliance.

Maintains a body of knowledge regarding all health care and health IT laws and regulations, including but not limited to:

Skilled Nursing Facilities Payment System

Reviews, revises, and/or drafts policies and procedures to meet regulatory requirements

Two years’ experience working in a healthcare regulatory affairs department.

Certification in Healthcare Compliance (CHC) preferred, or ability to obtain certification within two years.

Applicable healthcare industry experience such as experience with hospitals, FQHC’s, and governmental healthcare regulations are desired.

Detail-oriented with exceptional organizational and time management skills.

5 years of regulatory affairs experience in the [industry] sector.

Knowledge of current US & Global regulations pertaining to flavor & fragrance industries

Knowledge of WERCS, Oracle, AS/400

Proven ability to interpret and implement regulatory requirements.

Excellent communication, analytical, and problem-solving skills.

Manage labeling projects from planning to execution, ensuring accuracy and compliance with regulatory requirements.

Knowledge of regulatory requirements for labeling in the Nutrition industry.

Work with manufacturers to ensure compliance with US dietary supplement and food product labeling requirements.

Ability to work in a fast-paced environment and manage multiple projects simultaneously.

Strong communication and collaboration skills.

Collaborate with internal cross-functional teams to ensure labeling timelines align with product launch timelines.

·Manage and scope out multiple labeling projects in a highly cross-functional environment.

·Experience working independently and a track record of taking initiative

·Experience working with large data sets and keeping the quality high.

·Experience in Excel and/or SQL

·Impeccable communication and relationship-building skills

·Drive labeling workflows and projects success metrics and timeline.

Initiate change requests for new and revised labeling, work with Labeling Coordinators to create, maintain, and implement compliant labeling.

Good understanding of how labeling systems communicate with other business systems

Ability to lead team efforts on labeling projects.

Able to perform work with a high degree of accuracy and minimal supervision.

Commitment to learn and stay abreast of medical devices regulations. Understand the overall business environment, the orthopedic industry, and the marketplace.

* Please note, this position is a hybrid role, that sits partially onsite, in Warsaw, Indiana.

Experience in the ag-chem or other chemical industry helpful to understand the critical nature of labeling accuracy and requirements.

This position does not require creativity design experience. It requires more attention to details and organizational skills.

Attention to detail skills a must!

Ability to learn new technology applications. Adobe Creative Suite (InDesign, Illustrator) knowledge a plus.

Clerical and critical thinking skills.

Creates California Printer’s Proofs for Regulatory Specialists submissions.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

May develop and/or oversee budgets; manage finances including monitoring, analyzing, forecasting, and reporting.

Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.

Manage and contribute to the development of outreach strategy that may include relationship development, communications and compliance.

Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.

Demonstrated creativity, problem solving, critical analysis, initiative, judgment and, decision-making skills.

Follows Global Labeling procedures and maintains relevant databases and document management systems for assigned products.

Manages compounds with a high degree of complexity from a labeling perspective.

Works with customer experience, packaging engineering, and branding, HF, and artwork center to create layout templates for use in HF studies.

5+ years of experience in global and/or local regulatory labeling within the pharmaceutical industry.

Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.

Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!

Knowledge of Agile Software Document Management Solution.

Good analytical and problem-solving skills

Strong written and oral communication skills

Working on Service manuals, IFUs, knowledge of medical symbols

Basic knowledge of QSR/GMP (preferred).

Basic experience w/ print publishing, design, or document control programs.

Detail-oriented, self-starter with excellent communication and time management skills.

Liaison for DTRA STMs and PMs, project team and line management, with USAMRDC Office of Human and Animal Research Oversight (OHARO)

Experience meeting regulatory requirements for early research involving human and animal subjects

Knowledge of the DoD acquisition policies, preferably with experience in the Joint CBDP

Minimum of two years’ experience with a BS, or 1 year with a MS.

Experience with the DoD Joint Chemical Biological Defense Program (CBDP)

Track record of successful management of projects / work packages to meet agreed budget and schedule

Requires knowledge of reciprocal effects of work upon other fields.

3+ years of professional experience, preferably with an environmental consulting organization, an operator, contractor or regulator

Excellent client and agency interfacing skills

Competitive and comprehensive compensation, benefits package

Opportunities to integrate into engineering and project delivery to deliver meaningful benefits to the environment and communities

Incredible company culture and proven management team

MS WORD knowledge with WORD styles to format various documents for regulatory submissions

ECTD publishing experience with using eCTD software to produce a compliant electronic submission

3+ years of Regulatory Proofreading/Publishing experience within biopharma, medical device, IVD, or CRO industries (protocols, amendments, IBs, CSRs, INDs, NDA modules)

QC experience is a plus

REMOTE | Regulatory Publishing/QC opportunity with a well-funded Rare Disease biotech

Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).

Ensures that all regulatory labeling items and information is appropriately tracked, archived, searchable and accessible.

Works directly with Regulatory Project Mangers to prepare labeling items consistent with content project plans.

Base salary range of $65,000 to $85,000 per year, depending on education, experience, knowledge, skills, and abilities

Maintain accurate, operational, and functional quality databases related to product specifications and regulatory Information, including label management

Support packaging quality control and management

Manage 3rd party certifications for products

Manage relevant QA programs as assigned

Manage document and version control for operations related documents and programs

Knowledge of global regulatory requirements

Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

Responsible for regulatory compliance with pre- and post-approval filings and reporting requirements

Minimum 10+ years’ regulatory strategy background with experience in the MDS, AML, or MM space

Preferences include recent successful NDA experience, as well as experience within a matrix environment

Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.

Section 5: What skills you will learn? What experiences might you have?

Trained and acting in-person coverage for quality assurance (QA) personnel, as well as helping manage QA union inspectors when needed

Minimum Education: B.S. Chemistry or related science

Minimum Years of Experience: 1-3 years of Cosmetic or related industry experience

Special Requirements of the Position: French speaking a plus

Communication skills (both internal and external)

Excellent project management, and critical thinking skills

Reviews domestic and/or international labeling for compliance to labeling requirements including content, format and regulatory submissions

10+ years of relevant experience

Advanced knowledge of the scientific principles of the drug development process

Advanced, broad knowledge of regulations pertaining to drug product labeling

Excellent oral and written and written communication skills

Must have intermediate to advanced excel skills; macro experience is preferred

Research new regulatory developments and reporting requirements

Must be analytical, detail oriented and have excellent communication skills

Experience with Accounting preferred but not required

Analyze the various data components within our SAP Business Objects proprietary Datawarehouse

Prepare regulatory filings with multiple government agencies including Form PF, Form SLT, Form Tic-B, Form PQR, Canadian filings, Annex IV