Regulatory Affairs Associate

Stark Pharma Solutions Inc; Piscataway Township (NJ); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

Stark Pharma is looking for a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices and pharmaceuticals. You will prepare and submit regulatory documentation, maintain compliance, and assist with FDA submissions to ensure adherence to regulatory standards.

The ideal candidate will have 1-3 years of experience in Regulatory Affairs and a Bachelor's degree in a related field. Strong communication skills and project management abilities are essential.

Qualifikationen

• 1-3 years of Regulatory Affairs experience in the pharmaceutical or healthcare industry.
• Working knowledge of FDA regulations and regulatory submission processes.
• Ability to manage multiple projects and deadlines.

Aufgaben

• Prepare and submit regulatory documentation for product approvals.
• Review product labeling and promotional materials for compliance.
• Monitor changes in regulations and communicate impacts.

Kenntnisse

Technical writing

Regulatory compliance

Project management

Verbal communication

Written communication

Ausbildung

Bachelor's degree in Regulatory Affairs or related discipline

Jobbeschreibung

Role: Regulatory Affairs Associate

Location: United States

Duration: Long Term contract

Position Summary

We are seeking a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices, pharmaceuticals, biotechnology products, or combination products. The successful candidate will assist in preparing regulatory submissions, maintaining regulatory documentation, monitoring compliance requirements, and supporting product registrations to ensure adherence to FDA and global regulatory standards.

Key Responsibilities

• Prepare, compile, review, and submit regulatory documentation to support product approvals and registrations.
• Assist in the preparation of FDA submissions, including 510(k), PMA, IND, NDA, ANDA, or other regulatory filings as applicable.
• Support regulatory strategy development for new products, product modifications, and market expansions.
• Maintain regulatory files, product registrations, licenses, and submission records.
• Review product labeling, promotional materials, and technical documentation for regulatory compliance.
• Monitor changes in U.S. and international regulations and communicate regulatory impacts to internal stakeholders.
• Collaborate with Quality Assurance, R&D, Clinical, Manufacturing, and Marketing teams to support regulatory initiatives.
• Assist with regulatory agency correspondence, inspections, audits, and information requests.
• Support change control assessments and evaluate regulatory impact of product or process changes.
• Participate in cross-functional project teams to ensure timely regulatory deliverables.

Required Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Biology, Chemistry, Biomedical Engineering, or a related scientific discipline.
• 1 3 years of Regulatory Affairs experience within the pharmaceutical, biotechnology, medical device, or healthcare industry.
• Working knowledge of FDA regulations, guidance documents, and regulatory submission processes.
• Strong technical writing, documentation, and organizational skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.
• Excellent verbal and written communication skills.