About the Role The Associate Director, Regulatory Affairs - Nonclinical Development is a strategic regulatory leader specializing in nonclinical drug development. This role is responsible for guiding ...
About the Role The Associate Director, Regulatory Affairs - Nonclinical Development is a strategic regulatory leader specializing in nonclinical drug development. This role is responsible for guiding ...
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About The Role The Associate Director, Regulatory Affairs - Nonclinical Development is a strategic regulatory leader specializing in nonclinical drug development. This role is responsible for guiding ...
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Associate Development Director information
See Snoqualmie, WA salary details
$23.1K - $38.9K
1% of jobs
$38.9K - $54.8K
3% of jobs
$54.8K - $70.7K
12% of jobs
$78.2K is the 25th percentile. Wages below this are outliers.
$70.7K - $86.6K
19% of jobs
The median wage is $93.3K / yr.
$86.6K - $102.4K
35% of jobs
$108.4K is the 75th percentile. Wages above this are outliers.
$102.4K - $118.3K
13% of jobs
$118.3K - $134.2K
6% of jobs
$134.2K - $150.1K
4% of jobs
$150.1K - $165.9K
3% of jobs
$165.9K - $181.8K
1% of jobs
$181.8K - $197.7K
2% of jobs
$23.1K
$102.5K
$197.7K
How much do associate development director jobs pay per year?
What does an Associate Development Director do?
What are the key skills and qualifications needed to thrive as an Associate Development Director, and why are they important?
What are common challenges faced by an Associate Development Director, and how can they be addressed?
What is the difference between Associate Development Director vs Development Manager?
| Aspect | Associate Development Director | Development Manager |
|---|---|---|
| Required Credentials | Bachelor's degree, experience in fundraising or program development | Bachelor's degree, experience in project management or fundraising |
| Work Environment | Nonprofit organizations, educational institutions, or community programs | Nonprofits, corporate social responsibility departments, or educational sectors |
| Employer & Industry Usage | Used in organizations with multiple development roles, focusing on strategy and oversight | Used in organizations emphasizing program or project execution |
The Associate Development Director typically focuses on supporting fundraising strategies, donor relations, and program development at a strategic level. In contrast, the Development Manager often handles day-to-day fundraising activities, event planning, and direct donor engagement. Both roles require similar credentials and are common in nonprofit and educational sectors, but their focus and responsibilities differ based on organizational size and structure.

Associate Director, Regulatory Affairs & Submissions - Nonclinical Development
Everett, WA • On-site
Full-time
Medical, Dental, Vision, Retirement, PTO
Re-posted 6 days ago
Altasciences rating
7.6
Based on 17 frontline employees who took The Breakroom Quiz
59th of 120 rated laboratories
Job description
About the Role
The Associate Director, Regulatory Affairs - Nonclinical Development is a strategic regulatory leader specializing in nonclinical drug development. This role is responsible for guiding regulatory strategy for preclinical programs, ensuring that nonclinical data packages (pharmacology, toxicology, and ADME) are positioned to support successful clinical entry and market application submissions.
The Associate Director partners closely with sponsors and cross-functional teams to translate complex nonclinical data into clear regulatory strategies, enabling efficient progression of small molecules, biologics, and advanced therapeutic products into the clinic.
What You'll Do Here
Provide strategic regulatory guidance focused on nonclinical development programs, including pharmacology, toxicology, and IND/CTA-enabling studies.
Develop and execute nonclinical regulatory strategies to support early-phase drug development and clinical trial applications.
Lead the preparation and critical review of nonclinical sections of regulatory submissions (IND, CTA, NDA/BLA), ensuring scientific rigor and regulatory compliance.
Conduct gap analyses of nonclinical data packages, identifying risks and defining mitigation strategies for regulatory success Interpret and apply global regulatory requirements (FDA, EMA, Health Canada, ICH,) related to nonclinical safety and pharmacology.
Serve as a subject matter expert during health authority interactions, including briefing documents and meeting support (e.g., INTERACT, pre-IND, scientific advice).
Collaborate with Nonclinical, Clinical, Toxicology, Pharmacology, DMPK, and Medical Writing teams to ensure aligned development strategies.
Translate complex scientific data into clear regulatory narratives and submission-ready documentation, leveraging strong medical writing expertise.
Support business development activities, including proposal strategy, regulatory input, and client consultations.
Contribute to and implement SOPs and best practices related to nonclinical regulatory science and submissions Mentor and guide junior regulatory professionals, fostering scientific and regulatory excellence.
What You'll Need to Succeed
PhD (preferred) or MSc in Pharmacology, Toxicology, Pharmaceutical Sciences, or related discipline or an equivalent combination of relevant experience and education.
8-10+ years of Regulatory Affairs experience with a strong focus on nonclinical drug development.
Demonstrated expertise in nonclinical components of IND/CTA submissions, including toxicology, pharmacology, and safety assessment.
Experience supporting a range of modalities (e.g., small molecules, biologics, gene therapies) and routes of administration.
Strong understanding of global regulatory frameworks governing nonclinical development (FDA, EMA, ICH M3, ICH S guidelines).
Proven track record of interpreting nonclinical data to inform regulatory strategy and risk assessment in various therapeutic areas, including but not limited to Endocrinology and Metabolism, CNS, Cognitive, Movement and Neuromuscular disorders, Ophthalmology.
Experience in medical writing and preparation of nonclinical regulatory dossiers.
Solid knowledge of GLP, GMP, and GCP requirements as applicable to the nonclinical development stage.
Excellent analytical, problem-solving, and project management skills.
Strong communication skills, with the ability to articulate complex scientific information to diverse stakeholders.
Leadership experience, including mentoring or managing regulatory or scientific staff.
Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Associate Director, Regulatory Affairs - Nonclinical Development including, but not limited to, for the following reasons:
The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.
The employee communicates frequently with Altasciences employees across Canada and the United States. As such, English is the main language used to correspond between offices.
The employee frequently communicates with English-only customers outside the province of Quebec.
What We Offer:
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences' Benefits Package Includes:
Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance &TelehealthPrograms
Altasciences' Incentive Programs Include:
Training & Development Programs
Employee Referral BonusProgram
Annual Performance Review
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About Altasciences
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Industry
Scientific research and development services
Company size
1,001 - 5,000 Employees
Headquarters location
Overland Park, KS, US