Regulatory Affairs Specialist

Responsible for ensuring that company products comply with all regulatory requirements and standards for safety and efficacy.

Job Requirements:

Bachelor's degree in a scientific or healthcare-related field. 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry. In-depth knowledge of FDA regulations, ICH guidelines, and global regulatory requirements. Experience with regulatory submissions, including INDs, NDAs, BLAs, and post-approval supplements. Strong project management skills with the ability to manage multiple projects simultaneously. Ability to collaborate with cross-functional teams, including R&D, clinical, and quality departments.

Preferred Skills:

Advanced degree (MS or PhD) in life sciences or a related field. Experience with electronic submission platforms (eCTD). Previous experience with biologics or advanced therapies. Knowledge of regulatory pathways for new drug applications in the EU, Japan, and other international markets. Certification in Regulatory Affairs (RAC).

Job Responsibilities:

Prepare, review, and submit regulatory documents to FDA and other global health authorities. Monitor and interpret regulatory developments and communicate potential impact to the team. Provide regulatory guidance throughout the product lifecycle, from development through post-market. Manage and maintain regulatory timelines to ensure timely submissions and approvals. Coordinate with cross-functional teams to ensure compliance with regulatory requirements. Support product labeling development and ensure labeling compliance with regulatory standards.

Pay Details: $36.00 to $48.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.