Job Description

This range is provided by GQR. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.

Base pay range

$100.00/hr - $150.00/hr

Associate Director, Regulatory Affairs (Contractor) 12-Month Assignment

Location: Remote (East Coast)

Duration: 12 months (with potential for extension)

Start Date: January 2026 (flexible)

Therapeutic Area: Rare Disease

About the Role

We are seeking an experienced Associate Director, Regulatory Affairs to join our Regulatory team on a 12-month contract assignment. This individual will play a key role in supporting both late-stage development and NDA submission activities , while also contributing to earlier-stage programs across our expanding pipeline.

The ideal candidate will have a strong background in global regulatory strategy, Health Authority interactions, and submission planning within a fast-paced biotech or pharmaceutical environment.

Key Responsibilities

• Support the development and implementation of regulatory strategies for products spanning early- and late-stage development.
• Lead and coordinate NDA and MAA submission activities , including authoring, reviewing, and compiling regulatory documents (e.g., clinical summaries, briefing documents, IND/NDA modules).
• Partner cross-functionally with Clinical, CMC, Nonclinical, and Program Management to ensure alignment and timely execution of regulatory deliverables.
• Serve as a Regulatory Affairs representative on cross-functional project teams , providing strategic input to clinical development plans and study designs.
• Support Health Authority interactions (e.g., FDA, EMA), including preparation of meeting requests, briefing packages, and responses to agency questions.
• Maintain awareness of current global regulatory requirements, guidance documents, and trends relevant to assigned programs.
• Contribute to process improvements and the development of regulatory templates and best practices.
• Mentor or provide oversight to junior regulatory team members or consultants as needed.

Qualifications

• Bachelors degree in life sciences or related field required; advanced degree (PharmD, PhD, MS) preferred.
• 710 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry, including hands-on experience with INDs and NDAs/BLAs .
• Proven track record supporting late-stage clinical development and NDA preparation/filings .
• Experience in early development regulatory strategy (INDs, pre-IND, CTA filings) strongly preferred.
• Demonstrated ability to work independently in a fast-paced, dynamic environment.
• Excellent written and verbal communication skills, with the ability to synthesize complex data into clear, actionable regulatory messages.
• Strong organizational skills and attention to detail, with a focus on execution and timelines.
• Duration: 12 months (potential for renewal or conversion to FTE)
• Hours: Full-time (40 hrs/week)
• Location: Remote (occasional travel may be required)
• Reports to: VP, Regulatory Affairs

Benefits

• Medical insurance
• Vision insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Student loan assistance
• Tuition assistance
• Disability insurance

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