GQR
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
Bachelor’s degree in life sciences or related field required; advanced degree (PharmD, PhD, MS) preferred.
7–10 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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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
Bachelor’s degree in life sciences or related field required; advanced degree (PharmD, PhD, MS) preferred.
7–10 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
#J-18808-Ljbffr