Regulatory Affairs Intern

Regulatory Affairs Intern

Under general supervision, the Regulatory Affairs Intern assists with daily tasks as needed. This individual may be responsible for liaising with other departments, external consultants and regulatory team to ensure technical files, registrations, certifications, declaration of conformities, SDSs and other relevant documentation are accurate and up-to-date. This individual will assist with legalization of letter of authorizations, certificates and other documentation as needed.

This individual will also assist in projects including, but not limited to, regulatory deliverables and claims software.

Key

Duties and Responsibilities:

• Support authoring of regulatory submission documents and preparation for regulatory interactions with global health authorities
• Perform literature searches and information gathering to obtain background information for development of regulatory document and support strategic program initiatives
• Assist in reviewing labeling and other marketing materials for regulatory compliance.
• Research relevant regulatory policies and/or regulatory intelligence
• Perform additional activities that involve regulatory support as they arise

Qualifications,

Education and/or Experience

Required:

• Currently pursuing or completed a 4-year degree or Masters in (chemistry, biology, regulatory affairs or clinical)
• Must be proficient with Microsoft Office, especially with Excel
• Demonstrates excellent written, oral, and interpersonal skills with personnel at all levels
• Exhibits a high degree of integrity, initiative and motivation
• Strong ethics and regulatory compliance awareness
• Attention to detail and ability to manage multiple tasks
• Capacity to work independently, with excellent time management and judgment in task prioritization
• Able to interact with multiple individuals in a positive, constructive manner and under a variety of circumstances
• Ability to quickly and effectively build relationships, interact, and communicate information with internal and external stakeholders
• Capability to understand technical information/science as it applies to products, and the ability to translate into a business context

Language

Skills:

• English required, bilingual (Spanish) a plus.

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

Work Environment:

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

AAP/EEO Statement:

CHEMENCE® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.