Job Description

Job Title: Regulatory Affairs Specialist

Locations: New Jersey Pennsylvania Massachusetts Connecticut Rhode Island Salt Lake City (UT) California

Duration: Long Term contract

Job Summary

We are seeking experienced Regulatory Affairs professionals to support regulatory strategy submissions and compliance activities across pharmaceutical biotechnology and medical device programs. This role will work closely with cross-functional teams to ensure products meet global regulatory requirements throughout development approval and commercialization.

The ideal candidate will have strong experience with FDA regulations regulatory submissions and lifecycle management activities in regulated environments.

Key Responsibilities

• Prepare review and support regulatory submissions including INDs NDAs BLAs 510(k)s PMAs amendments supplements and annual reports
• Develop and execute regulatory strategies to support product development and commercialization
• Ensure compliance with FDA EMA ICH and global regulatory requirements
• Collaborate with Quality Clinical R&D Manufacturing and CMC teams on regulatory activities
• Support change control assessments labeling updates and product lifecycle management
• Review technical documentation SOPs and regulatory filings for accuracy and compliance
• Support regulatory inspections audits and agency interactions
• Monitor evolving regulatory requirements and communicate impact to internal stakeholders

Required Qualifications

• Bachelors degree in Life Sciences Pharmacy Regulatory Affairs Engineering or related field
• 3 10 years of experience in Regulatory Affairs within pharma biotech or medical devices
• Strong knowledge of FDA regulations and global regulatory frameworks
• Experience supporting regulatory submissions and compliance activities
• Excellent communication technical writing and project management skills
• Ability to work cross-functionally in fast-paced environments

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