Regulatory Affairs Associate

Hi

My name is Karthik Mutyala and I am a Recruitment Manager with Stark Pharma Solutions specializing in opportunities across the Pharmaceutical Biotechnology Medical Device and Life Sciences industries.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions please send me your updated resume along with the best number and time to reach you.

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

• Bachelors 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.